The Consultant leads components of evidence evaluation and systematic literature review projects to support healthcare policy and market access decisions. Responsibilities include managing small-scale projects, mentoring junior staff, and developing deliverables such as reports, manuscripts, and presentations.
Parexel
171 Remote Job Openings at Parexel
The Project Specialist supports project planning, execution, and financial tracking while coordinating with cross-functional teams. Key duties include maintaining project documentation, preparing reports, and monitoring progress to highlight risks to stakeholders.
Lead research design and analytical strategies while developing statistical analysis plans and authoring reports. Oversee the quality control of statistical deliverables and direct biostatistical activities as the functional lead within a study team.
The Patient Engagement Manager supports the Clinical Trial Diversity & Patient Engagement Team in creating resources and plans to enhance patient centricity. Key duties include managing patient advocacy group relationships, tracking funding, and implementing an end-to-end Patient Engagement Framework.
Data Surveillance Analyst - based in South Africa, Poland, Romania, Lithuania
Parexel
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Full Time
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20 hours ago
Parexel
The Data Surveillance Analyst analyzes scientific and operational data to identify trends, outliers, and risks while developing Data Surveillance Plans. They are responsible for configuring surveillance technologies and presenting findings to cross-functional study and client teams.
Manage complex Phase 1-4 global clinical trials and provide oversight of CROs and vendors within a quality framework. Coordinate with cross-functional teams to ensure operational excellence and regulatory compliance of investigational sites.
The Data Management Lead provides technical expertise and serves as the primary point of contact for assigned studies to ensure quality and timely delivery of data. Responsibilities include managing study timelines, collaborating with cross-functional global teams, and ensuring compliance with regulatory guidelines.
Clinical Research Associate - Oncology - Southeast, South, or Northeast US - FSP
Parexel
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Full Time
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2 days ago
Parexel
The Clinical Research Associate acts as the primary site manager, overseeing all phases of clinical research studies to ensure data accuracy and subject safety. Responsibilities include conducting site visits, managing regulatory documentation, and maintaining relationships with investigators.
The CRA acts as the primary site manager, overseeing all phases of clinical research studies to ensure data accuracy and subject safety. Responsibilities include conducting site visits, managing regulatory documentation, and maintaining relationships with investigators.
The role involves executing systematic literature reviews (SLR) and providing scientific solutions to meet client objectives. Responsibilities include conducting research, analyzing data, and developing deliverables such as reports, manuscripts, and slide decks.
Lead and deliver site start-up and activation activities for clinical trials to ensure timely activation and compliance. Act as the primary point of contact for sites while managing regulatory packages and collaborating cross-functionally to meet study milestones.
The role is responsible for the end-to-end planning, coordination, and execution of Clinical Trial Applications across EU CTR and Rest of the World regions. This includes managing project timelines, regulatory documentation, and collaborating with cross-functional global teams to ensure compliant submissions.
The CRA acts as the primary site manager, overseeing clinical research studies to ensure data accuracy and subject safety. Responsibilities include conducting site visits, managing regulatory documentation, and maintaining relationships with investigators.
Lead the startup and activation phase of clinical trials by managing site identification, regulatory approvals, and investigator relationships. Ensure all documentation meets quality standards and coordinate site readiness for timely launch.
The role involves producing derived datasets, tables, figures, and listings using SAS while ensuring high-quality standards and regulatory compliance. Additionally, the position supports project start-up activities and provides mentorship to project teams.
Senior Clinical Research Associate - Oncology - Midwest or Southwest US - FSP
Parexel
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Full Time
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6 days ago
Parexel
The Senior CRA is responsible for the delivery of clinical studies at allocated sites, including preparation, initiation, monitoring, and closure. They act as the primary contact for study sites to ensure compliance with international guidelines and client procedural documents.
Clinical Data Manager - South Africa or Poland (Home-based) - FSP
Parexel
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Full Time
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6 days ago
Parexel
Lead or co-lead clinical data management activities for Phase I-IV studies, including eCRF design and Data Management Plan development. Coordinate with cross-functional teams and vendors to ensure high-quality data capture and timely query resolution.
Lead the implementation of data receipt agreements and configure import procedures for clinical trial data ingestion. Manage electronic data timelines, ensure regulatory compliance, and mentor team members to drive process improvements.
The role focuses on supporting the execution of Parexel's Quality Management System (QMS) strategy, including infrastructure, risk management, and process optimization. It also involves providing technical oversight for eQMS applications and supporting corporate quality during audits and inspections.
Draft, review, and negotiate clinical site agreements while ensuring compliance with local laws and ICH-GCP guidelines. Act as a liaison between internal teams and external sites to manage contract execution and mentor junior staff.
Medical Monitor/Study Physician/Medical Director - Home Based - FSP
Parexel
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Full Time
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6 days ago
Parexel
The role involves providing medical expertise and oversight throughout the preparation, conduct, and reporting phases of clinical trials. Key duties include preparing high-quality protocols and performing ongoing reviews of medical data.
Lead and perform GxP audits across clinical research phases to evaluate quality systems against regulatory requirements. Manage audit programs, coordinate internal global process audits, and provide consultancy on regulatory compliance and CAPA implementation.
Lead organizational readiness and change enablement strategies to drive the adoption of new processes, technologies, and AI initiatives across the enterprise. Partner with senior leadership and the AI Innovation CoE to foster sustainable behavior change and measurable business outcomes.
Execute end-to-end Systematic Literature Reviews (SLRs) and produce high-quality evidence deliverables such as reports, manuscripts, and posters. Support project management, business development activities, and maintain professional client relationships.
The Medical Writer is responsible for researching, creating, and editing clinical research documents for regulatory submission, including protocols, CSRs, and safety reports. They also act as the primary client contact and project lead to ensure high-quality deliverables and adherence to timelines.
Lead and support operational activities from start-up to close-out for assigned investigator sites to ensure compliance with timelines and laws. Coordinate the compilation of Investigator Initiation Packages and manage site activation activities in collaboration with regulatory groups.
Senior Regulatory Affairs AssociateΒ (Regional Submission Coordinator)
Parexel
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Full Time
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8 days ago
Parexel
Coordinate the preparation and submission of new drug applications and lifecycle management activities across assigned regions. Collaborate with global teams and subject matter experts to ensure timely and compliant regulatory filings.
Lead the global clinical operations strategy and execution of clinical trials to ensure delivery on time, within budget, and according to quality standards. Serve as the primary clinical liaison for sponsors and coordinate cross-functional teams across various regions and time zones.
Senior / Regulatory Affairs Consultant - Regulatory Labeling Strategist
Parexel
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Full Time
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9 days ago
Parexel
Lead the global regulatory labeling strategy and governance for complex life-changing therapies across international markets. Oversee the creation and maintenance of core labeling documents while ensuring compliance with FDA, EMA, and other global health authorities.
Investigator Contracts Lead (Contracts & Budgets Analyst) - South Africa, Spain, Italy or Israel (Home-based) - FSP
Parexel
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Full Time
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9 days ago
Parexel
The Investigator Contracts Lead manages direct site-facing contract and budget negotiations and oversees the execution of clinical study agreements. They are also responsible for managing the Per-Subject Cost process and collaborating with legal and finance teams to resolve budget issues.
Develop and publish high-quality regulatory submissions to global health authorities in compliance with established standards. Provide support to internal and external stakeholders throughout the submission process.
The Medical Manager is responsible for delivering medical monitoring and pharmacovigilance support to ensure the successful execution of clinical trials. This includes reviewing study documents, managing safety reporting, and providing medical expertise to sponsors and internal teams.
The role involves managing clinical sites from initiation to close-out, ensuring adherence to study protocols and ICH-GCP guidelines. Key duties include performing site visits, managing study supplies, and maintaining trial management systems like CTMS and TMF.
Senior Regulatory Affairs Associate- Clinical Trial Application
Parexel
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Full Time
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12 days ago
Parexel
Lead the end-to-end planning, coordination, and execution of Clinical Trial Applications (CTA) across EU CTR and Rest of the World regions. Ensure timely and compliant submissions through cross-functional collaboration and proactive risk management.
The specialist is responsible for conducting feasibility assessments for sponsor-dedicated projects. This involves evaluating the viability of clinical trials and coordinating with sponsors.
Manage the end-to-end RFP process, including analyzing documentation, coordinating with subject matter experts, and developing strategic proposals and budgets. Create and finalize client contracts and budgets while negotiating terms and costs to ensure timely signatures.
Draft, review, and negotiate clinical site agreements and related legal documents while ensuring compliance with laws and ICH-GCP guidelines. Act as a primary liaison between internal teams and external sites to manage contract execution and track milestones.
The Project Manager is responsible for leading early-phase clinical trials from initiation to close-out, ensuring they are completed within budget and schedule. This includes managing sponsor relationships, overseeing study start-up, and mitigating project risks.
The Clinical Data Manager is responsible for planning and executing data management tasks for phase 1-4 clinical studies. This includes designing eCRFs, developing data management plans, and managing data queries and database lock activities.
Lead the negotiation and execution of clinical investigator site contracts and budgets across South Africa, Israel, Spain, and Italy. Manage the Per-Subject Cost process and collaborate with legal and finance teams to resolve budget and non-legal term issues.
Vendor Start Up Manager - IRT - Romania/Poland/Spain - FSP
Parexel
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Full Time
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13 days ago
Parexel
The Vendor Start Up Manager ensures accelerated and compliant vendor service delivery for IRT services during the trial start-up phase. Key duties include managing vendor budgets, reviewing protocols, and mitigating risks to ensure timely site readiness.
Responsible for planning and submitting EUCTR Part II applications via the CTIS database at a program level. Coordinates with Regulatory Affairs and Clinical Trial Management to ensure compliance with national regulatory requirements and trial timelines.
Design and implement API-led connectivity solutions using MuleSoft to integrate clinical systems while ensuring regulatory compliance. Configure and maintain automation workflows using Power Automate, Azure Logic Apps, and UiPath to improve operational efficiency.
Medical Director/Study Physician - Remote - Sponsor Dedicated
Parexel
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Full Time
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14 days ago
Parexel
The Study Physician provides medical expertise and oversight throughout the preparation, conduct, and reporting phases of clinical trials. Key duties include authoring high-quality protocols and managing trial risks and medical data reviews.
Design, develop, and maintain advanced Linux/Unix computer systems and infrastructure solutions for mission-critical applications. Provide technical oversight for physical and virtual servers across on-premises and cloud environments while managing software technical standards.
Support global regulatory lifecycle management and strategy development for EU, US, and international markets. Coordinate the preparation and delivery of regulatory submission packages and manage post-approval changes and Health Authority queries.
Support global regulatory lifecycle management and strategy development across EU, US, and international markets. Manage the preparation and delivery of regulatory submission packages and handle Health Authority queries.
Support global regulatory lifecycle management and strategy development across EU, US, and international markets. Prepare and deliver regulatory submission packages while managing post-approval changes and Health Authority queries.
Regulatory Affairs Consultant - CMC vax/bio (home or office based)
Parexel
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Full Time
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15 days ago
Parexel
Develop and execute submission strategies for post-approval CMC activities, including variations and renewals for vaccines and biologicals. Coordinate with cross-functional departments to review study reports and ensure compliance with global regulatory requirements.
Senior Regulatory Affairs Associate - CMC biologics/vaccines (home or office based)
Parexel
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Full Time
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15 days ago
Parexel
Develop and execute submission strategies for post-approval CMC activities, including variations and renewals for biologicals and vaccines. Coordinate with cross-functional departments to review study reports and ensure compliance with global regulatory requirements.
IRT Vendor Start-up Manager - UK or Ireland (Home-based) - FSP
Parexel
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Full Time
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15 days ago
Parexel
The Vendor Start-up Manager provides technical expertise for IRT vendors from study start-up to close-out to ensure flawless service delivery. Key duties include managing vendor budgets, reviewing protocols, and implementing risk mitigation plans to de-risk study start-up.
Implements and monitors clinical trials to ensure compliance with local regulatory requirements and ICH GCP guidelines. Responsible for site qualification, data verification, and mentoring junior-level CRAs.
Data Surveillance Analyst - based in South Africa, Poland, Lithuania
Parexel
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Full Time
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15 days ago
Parexel
The Data Surveillance Analyst analyzes scientific and operational data to support the Data Surveillance process and reviews Quality Tolerance Limits. They develop Data Surveillance Plans and present findings on trends and risks to internal and external project teams.
Senior Clinical Research Associate/Clinical Research Associate II - Oncology - Northeast or Central US - FSP
Parexel
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Full Time
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16 days ago
Parexel
Responsible for site management, monitoring, and close-out of clinical trials to ensure patient safety and quality execution. Acts as the primary point of contact for investigator sites to ensure compliance with GCP and sponsor standards.
Site Contracts Associate I or II - 6 month fixed term contract
Parexel
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Full Time
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16 days ago
Parexel
The role involves drafting and negotiating clinical study and service agreements while ensuring compliance with ICH-GCP and local laws. The associate manages the full contract lifecycle and acts as a communication hub between internal teams and external clinical trial sites.
Clinical Operations Assistant- Attention Clinical Site Coordinators!
Parexel
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Full Time
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16 days ago
Parexel
The Clinical Operations Assistant provides administrative support to Clinical Research Associates and project teams. Key tasks include managing site payments, supplies, trial master files, and processing Case Report Forms.
Lead global clinical logistics projects by developing strategic supply, sourcing, and distribution plans. Manage project budgets, timelines, and stakeholder relationships to ensure operational excellence and regulatory compliance.
The role involves managing clinical sites from initiation to close-out, ensuring adherence to study protocols and ICH-GCP guidelines. Key tasks include performing site visits, managing study supplies, and maintaining trial management systems to ensure data integrity.
Feasibility & Strategy Leader/ Senior Feasibility & Strategy Leader
Parexel
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Full Time
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20 days ago
Parexel
Lead the development of data-driven feasibility strategies to identify optimal countries, sites, and patient populations for clinical trials. Create high-quality proposal content and collaborate cross-functionally to win new business and drive innovation in feasibility processes.
The Associate provides statistical capabilities and methodological support throughout all project stages, from planning to completion. Key tasks include drafting statistical protocols, performing sample size calculations, and developing statistical programs to generate analysis datasets and reports.
Manage new registrations, renewals, and life cycle maintenance for biological products across major global markets. Lead and mentor team members on technical aspects of regulatory filings and submissions.
Senior Clinical Research Associate - Spain - Oncology - FSP
Parexel
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Full Time
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22 days ago
Parexel
The role involves managing all site and supervisory activities for assigned oncology studies for a single dedicated client. Responsibilities include monitoring sites and mentoring junior Clinical Research Associates.
The Senior CRA is responsible for the preparation, initiation, monitoring, and closure of clinical study sites in compliance with international guidelines and local regulations. Key duties include performing site visits, verifying source data, and ensuring the quality and integrity of collected study data.
The SCRA serves as the primary liaison between study teams and investigator sites, overseeing clinical trials from activation to database lock. Key duties include conducting site monitoring, ensuring protocol compliance, and managing operational deliverables to safeguard patient welfare.
Design, develop, and document complex Power Apps model and canvas driven applications to improve business processes. Provide architecture and functional support for Microsoft 365 technologies to enhance collaboration and productivity.
Serve as the primary technology advisor for strategic client accounts, aligning internal capabilities with client roadmaps and business goals. Coordinate across cross-functional teams to drive technical solutions and support commercial growth through proposals and contract negotiations.
Project Leadership β Biotech (clinical trials) βRespiratory - Home Based - (Future Needs)
Parexel
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Full Time
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24 days ago
Parexel
Lead project teams and manage day-to-day operations for global clinical trials to ensure on-time delivery within budget. Focus on achieving operational excellence and exceeding client expectations for Biotech clients.
Develop persuasive, differentiated proposal content and contracts to win new business for a leading Clinical Research Organization. Collaborate with senior leaders and cross-functional teams to align strategy and ensure high-quality delivery of client solutions.
R0000030967 Senior / Vice President, Technical - Clinical Regulatory Affairs (home-based)
Parexel
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Full Time
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a month ago
Parexel
Lead the Regulatory Strategy team by providing high-level technical and business consulting services to biopharma clients throughout the product lifecycle. Act as a trusted advisor to C-suite executives and represent clients before regulatory agencies to accelerate the delivery of therapies.
Project Leadership β Biotech (clinical trials) βNeurology/Psych/Rare Disease - Home Based - (Future Needs)
Parexel
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Full Time
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a month ago
Parexel
Lead global clinical trials for biotech clients in Neurology, Psychiatry, and Rare Disease therapeutics. Manage day-to-day operations, budgets, and project teams to ensure on-time delivery and operational excellence.
Project Leadership β Biotech (clinical trials) β Oncology - Home Based - (Future Needs)
Parexel
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Full Time
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a month ago
Parexel
Lead project teams in the day-to-day operations of global clinical trials to ensure on-time delivery within budget. Focus on achieving operational excellence and exceeding client expectations for Biotech clients.
Responsible for site management, monitoring, and close-out of clinical trial investigator sites to ensure patient safety and quality execution. This includes managing operational activities from site activation to database lock and coordinating with study teams and vendors.
Lead the implementation and configuration of eClinical platforms for clinical trials, ensuring timely start-up and compliance with study protocols. Serve as the primary technical point of contact for internal stakeholders and external clients regarding data integrations and system requirements.
The role focuses on strengthening global regulatory compliance and quality operations across GxP environments. Key duties include managing controlled documents, overseeing training governance, and leading inspection readiness for health authorities.
e-Clinical Business Lead, South Africa (office or home based)
Parexel
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Full Time
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a month ago
Parexel
Lead the implementation and configuration of eClinical platforms for clinical trials, ensuring timely start-up and compliance with protocols. Serve as the primary technical point of contact for internal stakeholders and external clients regarding data integrations and system requirements.
Design and code R and SQL programs to clean, validate, and analyze Real-World Data from sources like Optum and Flatiron. Develop programming plans, maintain auditable documentation, and create dashboards to communicate findings to study teams.
The role involves managing clinical sites from initiation to close-out, ensuring protocol adherence and data integrity. Key tasks include performing on-site and remote monitoring visits, managing site documentation, and maintaining compliance with ICH-GCP guidelines.
Manage the end-to-end RFP process, including analyzing documentation, coordinating with subject matter experts, and developing strategic proposals and budgets. Create, negotiate, and finalize client contracts and budget amendments in accordance with company SOPs and guidelines.
Coordinate and execute regulatory submissions and labeling activities for biological products across assigned LATAM countries. Maintain regulatory systems and documentation while collaborating with cross-functional stakeholders to ensure compliant and timely delivery.
Senior Clinical Research Associate - Midwest/Central US - FSP
Parexel
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Full Time
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a month ago
Parexel
The Senior CRA is responsible for site management, monitoring, and close-out of clinical trials to ensure patient safety and quality execution. They serve as the primary contact for investigator sites and ensure compliance with GCP and sponsor standards.
Global Clinical Trial Leader - Sponsor Dedicated - Home based
Parexel
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Full Time
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a month ago
Parexel
The Global Clinical Trial Leader is accountable for the set-up, execution, and delivery of assigned clinical trials according to defined milestones and KPIs. They provide leadership to the trial team, manage risk mitigation, and ensure compliance with GCP and regulatory requirements.
The MLR Technical Reviewer manages content administration within Veeva Vault PromoMats and Medical platforms, including creating placeholders and uploading versions. They are responsible for reference linking, anchoring, and monitoring workflows to ensure high-quality assets and agency performance.
The role involves developing market access solution strategies and authoring competitive service proposals to help bring new medicines to patients. It also includes tracking new business activities, managing budgets, and collaborating with subject matter experts to expand account relationships.
The Global SSU Lead is responsible for the global execution of site activation for clinical trials, ensuring efficiency and compliance with SOPs and ICH/GCP. This includes developing site start-up strategies, managing CRO performance, and overseeing regulatory submissions and documentation.
Senior Clinical Research Associate - Phase I Oncology - Texas - FSP
Parexel
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Full Time
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a month ago
Parexel
The Senior CRA is responsible for site management, monitoring, and close-out of clinical trials to ensure patient safety and quality execution. This includes managing investigator relationships, resolving protocol issues, and ensuring compliance with GCP and Sponsor standards.
Perform medical review of complex safety cases and ensure compliance with global drug safety regulations and reporting timelines. Act as a Subject Matter Expert to mentor junior physicians and support audits, inspections, and process improvements.
The Clinical Laboratory Study Manager oversees the collection, tracking, and processing of biosamples and biomarker data in alignment with study protocols. They collaborate with cross-functional teams and vendors to ensure quality data delivery and regulatory compliance throughout the study lifecycle.
The Data Surveillance Analyst is responsible for analyzing scientific and operational data to support the Data Surveillance process and reviewing Quality Tolerance Limits. They develop Data Surveillance Plans and present findings to project teams to ensure data quality and compliance.
Provide quality event and audit support and consultancy for India Biostatistics and Statistical Programming teams. Partner with India team heads to support functional SOP updates and general quality initiatives.
Regulatory Operations Sr. Project Manager / θ¦εΆζεΊγγγΈγ§γ―γγγγΌγΈγ£γΌ οΌγγ«γͺγ’γΌγοΌ
Parexel
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Full Time
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a month ago
Parexel
Lead regulatory submission project management to ensure high-quality and timely filings to authorities such as the PMDA. Coordinate with cross-functional teams and external vendors to manage submission plans, timelines, and document consistency.
Lead data quality and management activities for oncology clinical trials, focusing on risk management and stakeholder engagement. Oversee external data vendors and ensure the integration of ancillary systems while managing project resources and budgets.
Senior Regulatory Consultant β Advertising & Promotion (Strategic Lead)
Parexel
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Full Time
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a month ago
Parexel
Serve as a strategic regulatory advisor and subject matter expert on FDA advertising and promotion regulations for cross-functional teams. Independently review promotional materials and lead regulatory review committees to ensure compliant and effective healthcare communications.
Oversee a team of clinical operations professionals to ensure high-quality, timely delivery of project deliverables and resource allocation. Manage staff development, performance reviews, and contribute to business development through project bids and client presentations.
Develop and adapt health economic models to evaluate the cost-effectiveness of health technologies for global reimbursement. Perform data analysis and conduct systematic searches of scientific literature and HTA bodies to support project execution.
Responsible for negotiating, finalizing, and executing site contracts and budgets required for clinical trial site activation. Manages post-activation contract amendments and ensures all agreements comply with regulatory requirements and ICH-GCP guidelines.
Drive pricing strategy and commercial positioning for new and existing business opportunities while overseeing bid review and approval processes. Collaborate with finance and leadership to develop rate cards, budgets, and financial incentives to drive business growth.
Lead and manage a team to ensure the high-quality and timely delivery of project deliverables while mentoring junior staff. Oversee performance management, resource allocation, and maintain strong relationships with clients and project leadership.
Accountable for the operational and scientific oversight, set-up, and delivery of assigned clinical trials at the local level. Responsibilities include managing trial budgets, ensuring GCP-ICH compliance, and providing leadership to the wider trial team.
Senior Clinical Research Associate/Clinical Research Associate - FSP
Parexel
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Full Time
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a month ago
Parexel
The CRA is responsible for the preparation, initiation, monitoring, and closure of assigned clinical study sites to ensure compliance with international guidelines and local regulations. They act as the primary contact for study sites, managing data quality, drug accountability, and reporting of serious adverse events.
Senior Clinical Research Associate - Poland (Warsaw/ Lodz/ Trojmiasto/Bydgoszcz/ Cracow/Katowice)- FSP
Parexel
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Full Time
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a month ago
Parexel
Responsible for all site management and supervisory activities within assigned oncology studies for a single dedicated client. The role includes mentoring junior CRAs and utilizing world-class technology to support the drug development process.
Senior Regulatory Affairs Consultant (Program / Client Partnership Manager)
Parexel
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Full Time
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a month ago
Parexel
Lead midsize to large Regulatory Affairs outsourcing programs and act as a trusted advisor to clients on complex regulatory challenges. Drive business growth through proposal support, bid defense, and strategic account planning while mentoring project leaders.
The Local Study Associate Director leads local study teams to deliver clinical trials according to budget, timelines, and regulatory requirements. They oversee site identification, qualification, monitoring, and the management of essential trial documentation.
The Local Study Associate Director leads local study teams to deliver clinical trials according to budget, timelines, and regulatory guidelines. They oversee site identification, monitoring activities, and ensure the completeness of essential trial documentation.
The Local Study Associate Director leads local study teams to deliver clinical trials according to budget, timelines, and regulatory guidelines. They oversee site identification, monitoring, and the management of essential trial documentation and regulatory submissions.
Senior Clinical Research Associate/Clinical Research Associate - FSP
Parexel
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Full Time
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a month ago
Parexel
The CRA is responsible for the preparation, initiation, monitoring, and closure of assigned clinical study sites to ensure compliance with international guidelines and local regulations. They act as the primary contact for study sites, managing site performance, data quality, and the reporting of serious adverse events.
The Local Study Associate Director leads local study teams to deliver clinical trials according to budget, timelines, and regulatory guidelines. They oversee site identification, monitoring, and the management of essential trial documentation and regulatory submissions.
Senior Clinical Research Associate/Clinical Research Associate - All US Locations - FSP
Parexel
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Full Time
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a month ago
Parexel
The CRA is responsible for the preparation, initiation, monitoring, and closure of assigned clinical study sites in compliance with international guidelines and local regulations. They act as the primary contact for study sites, ensuring data quality, patient safety, and timely reporting of adverse events.
eClinical Business Lead - based in Romania, Serbia, Poland, Spain, South Africa
Parexel
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Full Time
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a month ago
Parexel
Lead the implementation and configuration of eClinical platforms for clinical trials, ensuring quality delivery and compliance with protocols. Serve as the primary technical point of contact for internal stakeholders and external clients regarding system integrations and requirements.
Medical Director/Senior Medical Director - Neurology or Psychiatry - TALENT SEARCH
Parexel
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Full Time
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a month ago
Parexel
The role involves providing medical monitoring and pharmacovigilance support for clinical research projects to ensure successful delivery. Additionally, the position requires building client relationships and providing medical expertise during the drug development and protocol design phases.
Manage the end-to-end global labelling lifecycle, including preliminary assessment, implementation, and post-approval maintenance. Collaborate with regional teams to ensure compliance with country-specific regulatory requirements and maintain labelling databases.
Lead the design and implementation of the Enterprise Data Lake using medallion architecture to deliver standardized data products across clinical and corporate domains. Manage global data engineering teams and partner with cross-functional stakeholders to ensure high-quality, governed data movement.
Project Leadership β Biotech (clinical trials) βDermatology - Home Based - (Future Needs)
Parexel
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Full Time
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a month ago
Parexel
Lead global clinical trials for biotech clients, managing day-to-day operations to ensure on-time delivery within budget. Drive operational excellence and exceed client expectations through effective project team leadership.
Provide medical monitoring and consultation for assigned clinical projects, acting as the medical representative and technical lead. Responsibilities include reviewing adverse experience reports, safety data, and supporting the preparation of clinical protocols and regulatory documents.
Medical Communications, AI Strategy and Implementation Lead
Parexel
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Full Time
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a month ago
Parexel
Lead the execution of the Medical Communications AI strategy by identifying high-value opportunities and designing AI agents to automate tasks. The role involves end-to-end implementation of AI solutions, mentoring staff, and providing strategic AI input for key accounts and proposals.
Principal Compliance Consultant - Data Integrity exp is a plus
Parexel
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Full Time
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a month ago
Parexel
Serve as a senior advisor to clients on FDA regulatory expectations and lead inspection readiness and mock inspection programs. Guide organizations through remediation planning and the resolution of complex compliance challenges such as Warning Letters and Consent Decrees.
Lead the global strategy, operations, and financial management of the enterprise network environment, including SD-WAN, firewalls, and connectivity services. Manage vendor relationships and optimize spending while ensuring network performance, security, and scalability across global sites.
Project Leadership - Mid/Large- (clinical trials) - Homebased - (future needs)
Parexel
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Full Time
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a month ago
Parexel
Lead global clinical trial project teams and manage day-to-day operations for mid to large biotech and pharma clients. Ensure operational excellence through on-time delivery within budget and high-quality standards to exceed client expectations.
Lead internal projects for clients by managing the full project lifecycle from initiation and execution to implementation and closure. Responsible for maintaining client relationships, managing budgets, and ensuring compliance with quality standards and local regulations.
Provides clinical and scientific expertise to develop trial strategies, protocols, and training materials. Manages relationships with investigative sites and oversees Data Monitoring Committees to ensure study success.
Responsible for site management, monitoring, and close-out of clinical trials to ensure patient safety and quality execution. Acts as the primary point of contact for investigator sites and ensures compliance with GCP and client standards.
Regulatory Affairs Consultant - Clinical Regulatory Affairs
Parexel
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Full Time
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2 months ago
Parexel
Serve as the Regulatory Affairs Lead for multiple clinical studies, providing strategic guidance and managing health authority communications. You will coordinate regulatory submissions, assess the impact of protocol amendments, and partner with cross-functional teams to ensure compliant trial execution.
The iCRA is responsible for managing the start-up, Pre SIV, and activation phases of clinical trials, acting as the primary contact for assigned sites. This includes handling regulatory submissions, negotiating agreements, and ensuring the quality of the Trial Master File.
Drive study performance at sites by performing monitoring visits and ensuring compliance with procedural documents and ICH-GCP guidelines. Manage essential documentation, drug accountability, and data query resolution while coordinating with local study teams.
Training Development Lead, Manager (Clinical Trial L&D Experience required) - UK (Remote) 12 Month Contract - FSP - REGISTER YOUR INTEREST
Parexel
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Full Time
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2 months ago
Parexel
The role involves managing courseware development, including design, publishing, testing, and deployment. It also requires providing technical and instructional design expertise while ensuring compliance with training and education regulatory requirements.
The role involves managing clinical sites from initiation to close-out, ensuring adherence to study protocols and regulatory requirements. Key duties include performing site visits, managing study supplies, and maintaining trial management systems to ensure data integrity.
Lead and manage the clinical operations portion of projects, including study start-up, execution, and close-out activities. Act as the primary liaison for sponsors and vendors while ensuring compliance with ICH-GCP guidelines and quality standards.
Lead and facilitate the risk management process for clinical projects, ensuring mitigation strategies are implemented and effective. Oversee quality compliance, manage SOP deviations, and ensure audit and inspection readiness across accounts.
Senior Clinical Research Associate - Sponsor Dedicated - Oncology Experience Needed
Parexel
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Full Time
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2 months ago
Parexel
Responsible for site management, monitoring, and close-out of clinical trial investigator sites to ensure patient safety and quality execution. This includes managing operational activities from site activation to database lock and coordinating with study teams and vendors.
Design and develop high-quality APIs and data integrations using the MuleSoft Anypoint Platform. Support existing integration architecture and collaborate with internal teams and vendors to improve software delivery through DevOps and Agile practices.
Regulatory Affairs CMC Senior Associate / Consultant - Biologics or Vaccines
Parexel
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Full Time
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2 months ago
Parexel
Lead and contribute to global CMC regulatory strategies and lifecycle activities for biologics and vaccines. Author and review high-quality CMC documentation (Modules 1-3) and manage global submissions across US, EU, and international markets.
The role involves preparing general ledger journal entries and managing the monthly close process for LATAM entities. Responsibilities include ensuring accuracy of financial statements under US and Local GAAP and supporting tax filings and audits.
Responsible for defining and delivering global study start-up strategies and managing site activations for medium to large interventional studies. This includes coordinating regulatory submissions, contracts, and budgets to ensure milestones like the first subject first visit are met.
Senior Clinical Research Associate (Oncology Experience Required) - UK (Remote) - FSP - REGISTER YOUR INTEREST
Parexel
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Full Time
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2 months ago
Parexel
The Senior CRA is responsible for ensuring data integrity, quality, and compliance with ICH GCP and local requirements at the site level. This includes conducting virtual and on-site monitoring, managing protocol deviations, and collaborating with Site Managers to ensure inspection readiness.
The role involves producing and quality-checking derived datasets, tables, figures, and listings using SAS for clinical projects. It also includes coordinating project start-up activities and ensuring compliance with regulatory standards and SOPs.
The role involves providing insights-driven clinical and consulting solutions to the life sciences industry. The clinician will work with biopharmaceutical leaders to design and deliver clinical trials with a focus on patient access.
Trial Vendor Senior Manager - UK, Ireland, France (Home-based) - FSP - REGISTER YOUR INTEREST
Parexel
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Full Time
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2 months ago
Parexel
Independently manage all vendor-related aspects of global clinical trials to ensure outcomes meet schedule, budget, and quality standards. This includes overseeing vendor selection, contract amendments, cost control, and operational deliverables throughout the study lifetime.
The Senior Clinical Research Associate is responsible for site management, monitoring, and close-out of clinical trial investigator sites to ensure patient safety and quality study execution. They manage investigator site relationships and resolve protocol-related issues while ensuring compliance with applicable laws and standards.
The Study Operations Manager leads local study teams and oversees CROs to ensure operational delivery from study startup through close. Responsibilities include managing timelines, budgets, recruitment strategies, and regulatory submissions to Health Authorities and Ethics Committees.
The role focuses on aggressively prospecting and acquiring new business opportunities within specified customer accounts to drive growth. It involves developing strategic sales plans, leading proposal strategies, and maintaining high-level relationships with key decision-makers to become a trusted advisor.
The Site Payment Lead coordinates site payment setups and modifications within investigator payment systems across assigned clinical studies. They serve as the primary point of contact for project teams to ensure timely payments and compliance with contractual terms.
Responsible for the strategy, adoption, and operational management of the Microsoft 365 platform to maximize business value. This includes optimizing M365 services, driving Copilot adoption, and ensuring platform security and compliance.
Project Leader / Senior Project Leader - Biotech (Select EU countries)
Parexel
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Full Time
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2 months ago
Parexel
Lead the delivery and oversight of clinical trials for Biotech clients, ensuring projects are completed on time, within budget, and in compliance with ICH GCP. Manage cross-functional teams and maintain strong client relationships while overseeing project P&L and risk mitigation.
The Investigator Contracts Lead is responsible for negotiating clinical site contracts and budgets while overseeing contracting professionals on assigned studies. They also manage the Per-Subject Cost process and collaborate with legal and finance teams to ensure study timelines are met.
The Investigator Contracts Lead will negotiate and execute global clinical study agreements and site budgets while managing relationships with investigators and institutions. They will also partner with Legal and Finance teams to resolve escalations and implement process improvements for site contracting.
The Clinical Supply Support Specialist is responsible for monitoring clinical supply levels, managing comparator drug procurement, and overseeing shipment logistics. They also maintain electronic trial master file documentation and provide support for IRT system management and user access.
The Executive Director is responsible for leading a service line, managing project profitability, and driving business development within the HEOR Consulting group. They also play a key role in implementing AI-driven methodologies and providing strategic leadership to cross-functional teams.
The Country Study Operations Manager oversees study-level activities from startup through closeout, ensuring compliance with global and local regulatory requirements. They lead local study teams, manage vendor deliverables, and drive recruitment and site activation strategies to meet study milestones.
The Manager, Project Planner is responsible for coordinating, monitoring, and reporting project schedules and resource management information to ensure alignment across development and commercial teams. They partner with project team members to identify schedule conflicts, manage risks, and perform scenario planning to optimize project delivery.
The Senior CRA is responsible for the site management, monitoring, and close-out of clinical trial sites to ensure patient safety and quality study execution. They act as the primary point of contact for investigator sites, facilitating information flow and ensuring compliance with GCP and protocol standards.
The role involves providing global leadership in clinical and laboratory supply chain management while ensuring operational excellence and regulatory compliance. You will be responsible for developing supply strategies, managing project budgets, and serving as the primary regulatory point of contact for clients.
Biotech Project Leadership - Clinical Trials - Home- Based - (Future Needs)
Parexel
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Full Time
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3 months ago
Parexel
The Project Leader will manage day-to-day operations of global clinical trials to ensure operational excellence and on-time delivery within budget. They are responsible for providing leadership to project teams and exceeding client expectations throughout the clinical development process.
The Project Manager will oversee the planning, collection, processing, and transfer of clinical trial samples while ensuring compliance with study protocols. They will act as a liaison between internal stakeholders, clinical sites, and vendors to resolve sample-related issues and support biomarker evaluation.
The Country Study Operations Manager oversees study-level activities from startup through conduct and closeout, ensuring compliance with global and local regulations. They lead local study teams, manage vendor deliverables, and implement risk mitigation strategies to ensure timely study delivery.
The Site Care Partner acts as the client's representative, ensuring sites receive necessary support, resolving issues, and upholding the client's reputation throughout the study lifecycle, from site start-up through activation and ongoing operational oversight.
The Clinical Research Associate is responsible for maintaining data integrity and quality, ensuring site compliance with ICH GCP and local requirements, and acting as the primary contact for assigned clinical sites from initiation through close-out. Key duties involve performing monitoring visits (virtual and on-site), resolving site issues, assessing site performance, and managing study documentation and systems.
The Senior Regulatory Affairs Associate is responsible for submitting labelling and safety variations in EU countries, including the UK and Ireland. This involves the preparation and review of M1 documents such as Cover Letters, eAFs, Mock-ups, and Clinical Overviews, alongside updating impacted labelling documents.
Senior Regulatory Affairs Consultant - Labelling Strategy (home or office based)
Parexel
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Full Time
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4 months ago
Parexel
The Senior Consultant acts as the principal labeling strategist within Global Regulatory Affairs, driving the development and maintenance of key labeling documents like the CCDS, USPI, and EU SmPC for assigned products. This role ensures optimal alignment of company position, labeling requirements, and commercial opportunities while providing strategic input from a labeling perspective to the GRA Therapeutic Area Team.
Regulatory Affairs Consultant - Labelling Strategy (home or office based)
Parexel
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Full Time
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4 months ago
Parexel
The consultant will act as a labeling strategist, driving the maintenance of the Company Core Data Sheet (CCDS), US Prescribing Information (USPI), and EU Summary of Product Characteristics (SmPC) for assigned products. This includes leading the Global Labeling Committee assessment of proposed changes and ensuring global alignment of core product claims.
Senior Regulatory Affairs Associate - EU Regulatory Intelligence
Parexel
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Full Time
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4 months ago
Parexel
This role involves continuously monitoring, analyzing, and translating local, regional, and global regulatory developments into actionable insights for regulatory teams and stakeholders. Key duties include conducting impact assessments on regulatory changes and actively engaging in industry forums to inform forward-looking regulatory strategies.
The Clinical Research Associate II implements and monitors clinical trials, ensuring sponsor and investigator obligations are met while adhering to local regulatory requirements and ICH GCP guidelines. Key duties involve assessing sites, initiating and closing trials, reviewing collected data, providing status updates, and resolving trial-related issues.
The Medical Director will provide medical monitoring for assigned projects, act as the medical representative on the project team, and offer medical consultation to clients or other Parexel service groups. Responsibilities also include reviewing adverse experience reports for accuracy and clinical importance, and summarizing safety data for regulatory agencies and sponsors.
Senior Regulatory Affairs Associate (Regulatory Intelligence)
Parexel
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Full Time
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4 months ago
Parexel
This role involves continuously tracking, analyzing, and translating local, regional, and global regulatory developments into actionable insights for regulatory teams and stakeholders. Key accountabilities include monitoring regulatory changes, conducting impact assessments, communicating updates clearly, engaging in external networking, and embedding intelligence into strategic planning across various internal functions.
The Clinical Research Associate II is responsible for conducting qualification, initiation, monitoring, and termination visits at assigned clinical sites, while building strong site relationships and resolving issues. This role also involves overseeing study integrity, protecting human subjects, driving patient recruitment strategies, and ensuring data quality and regulatory compliance.
Associate Project DirectorΒ - Regulatory Affairs Consulting (home or office based)
Parexel
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4 months ago
Parexel
This pivotal role involves leading Regulatory Affairs Consulting teams, delivering exceptional solutions, and acting as a trusted advisor to clients on complex regulatory challenges. Responsibilities also include driving operational excellence across outsourcing programs, managing projects from inception to completion, and generating new business.
The Site Care Partner acts as a crucial liaison for investigative sites, managing activities from start-up through close-out, including relationship management, recruitment oversight, and quality assurance.
As a senior leader, the Principal Consultant is responsible for building client relationships, providing technical leadership and training to junior staff, generating thought leadership, and leading complex project delivery to ensure quality and timeliness. This role also involves writing and presenting proposals, driving sales targets, and acting as Project Director on key engagements.
Project Leadership β Biotech (Clinical Trials) - GLP-1 / Obesity - Home Based
Parexel
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Full Time
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5 months ago
Parexel
Individuals selected for these roles will provide leadership to project teams and manage the day-to-day operations while striving to achieve operational excellence through on time delivery within budget and to the highest quality.
The Clinical Research Manager is accountable for end-to-end performance and project management for assigned protocols, ensuring compliance with regulations and quality standards. They serve as the main point of contact between country operations and the clinical trial team, leading local study teams and managing project deliverables.
The Executive Director will oversee the management and leadership of Parexel's Patient Safety pillar, specifically the Patient Safety Project Leadership Organization, providing oversight of processes related to program or portfolio delivery. This role involves leading operational planning, driving continuous process improvement, contributing to Business Unit strategy, and leading operational contributions to business development activities.
The Clinical Research Associate is responsible for maintaining the integrity of study implementation and adherence to study protocols at clinical sites. They will build relationships with site staff, resolve issues, and ensure compliance with regulations throughout the study lifecycle.
Clinical Research Associate/Senior Clinical Research Associate- FSP
Parexel
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Full Time
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6 months ago
Parexel
The Clinical Research Associate (CRA) is responsible for the delivery of studies at allocated sites, including preparation, initiation, monitoring, and closure of assigned sites. The CRA acts as the main contact with the study site and ensures compliance with international guidelines and local regulations.