The Bioinformatics Scientist will support clinical research by managing biomarker data analysis, automating processing pipelines, and ensuring data quality. They will also collaborate with cross-functional teams to build interactive data visualization tools and maintain standardized analysis workflows.
The Senior Statistical Programmer provides technical expertise for clinical trial analysis and reporting while acting as a lead for programming activities. They are responsible for ensuring project timelines, budgets, and quality standards are met while collaborating with sponsors and internal stakeholders.
Serve as a tier 3 escalation point for complex desktop, OS, and productivity application issues while performing root-cause analysis. Maintain standard computing environments and assist with the administration of Microsoft Intune and Azure Virtual Desktop.
The Clinical Research Associate is responsible for overseeing clinical trial monitoring, ensuring site compliance with protocols, GCP, and regulatory standards. They serve as the primary point of contact for investigator sites, managing operational activities from site activation through to database lock.
The Global Regulatory Labeling Lead will define and drive global labeling strategy while providing operational oversight for complex labeling initiatives across international markets. This role involves chairing governance committees, managing core labeling documentation, and ensuring compliance through cross-functional collaboration and health authority engagement.
The Regulatory Operations Submission Manager is responsible for planning, managing, and tracking global regulatory submissions to ensure timely and compliant delivery. This role involves leading cross-functional teams, maintaining submission timelines, and implementing quality control processes for all submission dossiers.
The role involves managing biomarker data pipelines, maintaining R packages, and ensuring data quality through rigorous validation and version control. Additionally, the scientist will support project tracking and develop AI-assisted coding standards to enhance team workflows.
The Senior Associate Bioinformatics Scientist will support data analysis, pipeline automation, and cross-study data integration for clinical trials. Responsibilities include performing quality control, maintaining data viewers, and developing AI-assisted analysis workflows.
The Senior Medical Writer will create and manage clinical documents such as CTRs, CTPs, and IBs within a dedicated sponsor-aligned environment. They are responsible for overseeing document review cycles, ensuring compliance with SOPs, and collaborating with trial teams to meet project timelines.
The Clinical Research Associate is responsible for the preparation, initiation, monitoring, and closure of assigned clinical study sites to ensure compliance with international guidelines and sponsor protocols. They act as the primary contact for study sites, driving performance and ensuring timely resolution of study-related issues.
The Senior Project Specialist is responsible for finalizing documentation for scientific leader engagements and ensuring compliance with internal policies. They will also manage logistics, oversee vendors, and maintain data repositories for medical education activities.
The Senior Statistical Programmer provides technical expertise to support clinical trial analysis and reporting activities while serving as a key contributor to high-quality statistical programming solutions. This role involves coordinating study start-up activities, developing SDTM datasets, and collaborating with cross-functional teams to ensure compliant study delivery.
The Statistical Programmer II will develop and quality control SDTM datasets to support regulatory submissions and clinical study decisions. They will collaborate with cross-functional teams and sponsors to ensure high-quality, compliant deliverables while supporting process improvements.
The Site Contract Leader acts as the primary point of accountability for sponsor engagement and site contracting strategy across global clinical trials. They oversee project-assigned teams to drive efficient negotiations, manage budgets, and ensure alignment with study objectives.
The Biostatistician II leads the development and execution of statistical aspects for clinical studies and contributes to trial design, protocol development, and analysis planning. They collaborate with cross-functional teams to interpret results and prepare regulatory submissions while ensuring high-quality statistical deliverables.
The Senior Biostatistician will lead research design and analytical strategies while overseeing statistical deliverables for clinical studies. They are responsible for mentoring junior staff, coordinating with clients, and ensuring the quality and accuracy of all statistical outputs.
The Manager, Production Services will provide operational leadership and technical oversight for clinical trial supply chain functions, including packaging, labeling, and production planning. They are responsible for ensuring compliance with GMP standards while mentoring team members and collaborating with global cross-functional teams to meet project timelines.
The Patient Compensation Lead is responsible for managing global participant payment processes, travel services, and vendor performance within clinical development. This role involves leading cross-functional initiatives to improve payment systems and ensuring adherence to quality standards and regulatory requirements.
The Senior Clinical Research Associate is responsible for the successful delivery of clinical studies at assigned investigator sites, including site management, monitoring, and study execution. They serve as the primary point of contact for sites to ensure high-quality data collection, regulatory compliance, and patient safety.
The Patient Compensation Lead is responsible for overseeing global participant payment strategies, vendor performance, and travel services within clinical development. This role involves leading process improvement initiatives and ensuring cross-functional alignment to deliver a patient-centric payment experience.
The role involves managing post-approval regulatory activities, including variations, renewals, and compliance with country-specific requirements. You will partner with cross-functional teams to ensure timely submissions and maintain regulatory dossiers.
The Director will provide operational leadership for the Patient Safety department, overseeing quality, compliance, and team development. They will manage projects, client relationships, and process excellence initiatives to ensure safety data integrity and operational efficiency.
The Senior Regulatory Strategist will serve as a subject matter expert, providing strategic guidance on FDA advertising and promotion regulations to cross-functional teams. They will independently review promotional materials and lead risk mitigation strategies to ensure compliance while supporting business objectives.
The manager oversees the operational aspects of clinical laboratory samples, including collection, processing, storage, and data transfer. They collaborate with cross-functional teams to ensure protocol compliance and support the delivery of high-quality data for clinical trials.
The associate will support biostatistical and programming tasks, including drafting statistical sections of protocols and developing statistical analysis plans. They will also perform quality control on analysis datasets and provide statistical input for clinical study reports.
The Site Contracts Associate is responsible for drafting, negotiating, and managing clinical trial agreements while ensuring compliance with local laws and ICH-GCP guidelines. They act as a central communication hub between internal teams, clinical sites, and external partners to ensure efficient contract lifecycles.
The Senior Regulatory Project Manager will partner with Global Regulatory Leads to shape and execute comprehensive regulatory strategies for global markets. They are responsible for driving cross-functional alignment, managing complex timelines, and ensuring the successful delivery of regulatory milestones for transformative vaccines.
The Site Payment Lead is responsible for managing investigator payments, coordinating with project teams, and ensuring accurate setup and budget alignment for clinical studies. They also act as the primary point of contact for payment-related queries and lead process improvements within the Site Payment Office.
The Regulatory Affairs Associate supports the compilation of core packages for Clinical Trial Applications and authors necessary documentation. They also manage submission logistics and ensure project deliverables meet quality and timeline expectations for clients.
Lead and contribute to global CMC regulatory strategies for commercial biologics and vaccine products. Manage post-approval regulatory activities, including variations, supplements, and lifecycle maintenance while ensuring compliance with global health authority expectations.
The Senior Clinical Research Associate is responsible for site management, monitoring, and close-out activities to ensure clinical trials are conducted in compliance with GCP and sponsor standards. They act as the primary point of contact for investigator sites, facilitating communication and ensuring data quality and patient safety throughout the study lifecycle.
The Manager of Site Payment Services will lead a global team to ensure the accurate and timely end-to-end management of investigator payments. They are responsible for driving operational excellence, implementing process improvements, and maintaining strong relationships with internal and external stakeholders.
The Data Surveillance Analyst is responsible for analyzing scientific and operational data to support the Data Surveillance process and reviewing project-specific Quality Tolerance Limits. They also configure surveillance technologies and present findings to project teams during internal and external meetings.
Lead and manage medium to high complexity clinical trials with full accountability for project deliverables, budgets, and quality standards. Own the client relationship at the study level while driving cross-functional team performance and regulatory compliance.
The General Ledger Accountant will manage monthly close processes, including journal entries, reconciliations, and financial reporting under US and Local GAAP. They will also support statutory financial statements, tax filings, and cross-functional intercompany transaction management.
The Site Activation Partner coordinates clinical trial site initiation activities, including the preparation and submission of essential regulatory documents. They also manage ongoing site compliance, maintain clinical trial systems, and act as a point of contact for study teams throughout the life cycle of the study.
Develop and execute global supply strategies for clinical and laboratory samples while ensuring strict regulatory compliance. Manage project timelines, budgets, and third-party provider contracts to ensure operational excellence.
The Project Specialist provides logistical and administrative support to global study management teams, including tracking study documentation and maintaining the Trial Master File. They also assist in coordinating vendor activities, site selection processes, and ensuring compliance with global standards and regulatory requirements.
The Site Activation Partner leads operational activities from study startup to close-out, ensuring compliance with study timelines, laws, and Good Clinical Practices. They coordinate essential document management, manage investigator site readiness, and act as the primary point of contact for site operations and regulatory submissions.
The Site and Monitoring Health Lead oversees CRO monitoring effectiveness and ensures high-quality clinical trial execution through risk-based assessments and sponsor oversight. They are responsible for developing study-specific oversight plans, addressing quality concerns, and preparing teams for regulatory inspections.
The Clinical Research Associate II acts as the primary contact for clinical sites, ensuring study protocol adherence, data integrity, and regulatory compliance. They are responsible for managing site relationships, conducting monitoring visits, and overseeing study documentation throughout the trial lifecycle.
Manage the full lifecycle of clinical site payment administration, including protocol schedules, startup payments, and invoiceable items. Ensure accurate configuration of systems and resolve payment escalations to maintain site satisfaction and operational continuity.
Manage the full lifecycle of clinical site payment administration, including protocol schedules, startup payments, and invoiceable items. Ensure accurate configuration of site contracts and budgets while troubleshooting payment failures to maintain operational excellence.
The Clinical Operations Assistant supports Clinical Research Associates and project teams with administrative tasks, site payments, and trial master file management. They are also responsible for tracking, scanning, and filing case report forms while maintaining limited contact with investigator sites.
The Investigator Contracts Lead II is responsible for managing direct site-facing contract and budget negotiations, including initial agreements and amendments. They also oversee other contracting professionals, manage per-subject costs, and collaborate with cross-functional teams to ensure timely site contracting and study execution.
The Medical Director serves as a global clinical lead and medical monitor, overseeing clinical trial execution and ensuring data quality for neuropsychiatric indications. They also contribute to strategic clinical development plans, regulatory documentation, and cross-functional team leadership.
The Medical Director serves as the Global Clinical Lead, overseeing medical monitoring, clinical data review, and the development of clinical trial protocols for neuropsychiatric therapies. They collaborate cross-functionally to ensure trial execution meets quality, time, and regulatory standards.
The GCO Associate provides operational support for clinical trial activities, including site activation, study conduct, and close-out processes. They manage site-facing communications, documentation, and contracting workflows to ensure compliance with regulatory requirements.
The Senior Business Analyst will drive strategic improvements in clinical research operations by analyzing complex business processes and translating stakeholder requirements into actionable solutions. They will lead process optimization initiatives, manage requirements, and collaborate with cross-functional teams to ensure system implementations meet quality and compliance standards.
The specialist provides administrative and operational support to the patient recruitment and retention team to ensure clinical trial objectives are met. Responsibilities include managing material approvals, tracking vendor reports, maintaining trial documentation, and assisting with system enhancements.
The Contract Specialist manages the end-to-end proposal and contract development process, including analyzing RFPs and coordinating with subject matter experts. They are responsible for creating accurate budgets, negotiating terms, and ensuring all documentation aligns with client specifications and internal policies.
Provide expert-level consulting in clinical pharmacology and regulatory strategy to guide biopharmaceutical sponsors through complex development programs. Lead client engagements and represent sponsors before global regulatory agencies while serving as a strategic advisor to senior leadership.
The Senior Associate is responsible for delivering high-quality consulting services and clinical outcome assessment projects under the guidance of project leads. They must effectively manage client relationships, identify project issues, and contribute to business development opportunities.
The FSP Program Lead oversees Data Management operations, managing client accounts, resourcing projects, and ensuring high-quality deliverables. They are responsible for line management of staff, performance monitoring, and serving as a key liaison between senior management and client personnel.
The Regulatory Strategy Senior Associate will develop regulatory pathway recommendations and support agency engagement planning for clinical products. They will also identify key regulatory risks and opportunities while ensuring compliance across cross-functional teams.
The Therapeutic Area Lead provides medical oversight and clinical excellence across complex trials, ensuring patient safety and regulatory compliance. They lead medical monitoring activities, support protocol development, and manage client relationships to deliver high-quality clinical research solutions.
The Regulatory Strategy Consultant will own and develop regulatory strategies for significant programs, providing leadership on authority engagement and high-impact submissions. They will collaborate with cross-functional teams to ensure alignment with business objectives and optimize regulatory pathways throughout the product lifecycle.
The General Manager will lead strategic customer relationships by overseeing operational delivery, financial performance, and team management within a large-scale clinical research portfolio. They are responsible for driving account growth, ensuring service quality, and serving as the primary executive point of contact for the client.
The Clinical Trial Leader is accountable for the end-to-end execution, delivery, and strategic oversight of complex global clinical trials. They lead cross-functional teams to ensure adherence to timelines, regulatory requirements, and quality standards while managing risks and stakeholder engagement.
The Senior Clinical Research Associate monitors and oversees clinical trials at client sites to ensure data quality, integrity, and regulatory compliance. They also manage site-specific activities, including feasibility, qualification, and the resolution of site-related issues throughout the trial lifecycle.
The Global Study Manager II provides operational leadership throughout the clinical trial lifecycle, ensuring quality execution of study management, site management, and vendor deliverables. They are responsible for setting operational strategy, managing budgets, and driving study milestones in collaboration with cross-functional teams.
The Meeting Specialist will lead all aspects of project deliverables for international pharmaceutical events, ensuring they are completed on time and within budget. This role involves managing client expectations, overseeing delegate travel, and coordinating with suppliers to deliver high-quality meeting experiences.
The Global Clinical Trial Leader is responsible for the planning, implementation, and operational feasibility of clinical trials while ensuring regulatory compliance and data accuracy. They lead cross-functional teams to manage study timelines, risk mitigation, and patient safety throughout the trial lifecycle.
The Global Clinical Trial Leader is responsible for the planning, execution, and operational feasibility of clinical trials while ensuring regulatory compliance and patient safety. They collaborate with cross-functional teams to manage trial timelines, risk mitigation, and the delivery of high-quality clinical data.
The consultant will support global regulatory lifecycle management, including the preparation and submission of regulatory packages across EU and US markets. They are also responsible for managing post-approval changes, handling health authority queries, and ensuring compliance with regulatory standards.
The Clinical Project Leader will provide cross-functional leadership for clinical trials, ensuring projects are delivered on time, within budget, and in compliance with ICH GCP standards. They are responsible for managing client relationships, project P&L, and mitigating risks throughout the project lifecycle.
The Director of Clinical Operations oversees a team of managers and individual contributors to ensure high-quality, timely project delivery within budget. They are responsible for talent development, resource planning, and driving business growth through client engagement and strategic leadership.
The Biometrics Delivery Lead is responsible for the execution of Data Operations strategy and technology setup for clinical projects. They provide leadership to global teams, manage budgets and resourcing, and serve as the primary point of contact for clients to ensure deliverables meet quality and timeline standards.
The Investigator Payments Lead manages the end-to-end lifecycle of clinical site payments, ensuring timely and accurate disbursements from study startup to close. They also provide oversight of vendor staff and troubleshoot complex payment issues to maintain site satisfaction and contractual compliance.
You will be responsible for all site management and supervisory activities for oncology studies while working with industry leaders. Additionally, you will mentor junior CRAs and ensure compliance with clinical research guidelines.
The consultant will manage regulatory project execution, including planning, financial forecasting, and ensuring quality deliverables for clients. They will also act as a primary client contact, identify new business opportunities, and mentor junior staff members.
The Clinical Trial Leader is accountable for the set-up, execution, and delivery of assigned oncology or inflammation clinical trials. They provide leadership to the trial team, manage project timelines, ensure regulatory compliance, and oversee risk mitigation strategies.
Lead, perform, and report a range of GxP audits across all phases of clinical research to ensure compliance with regulatory requirements. Manage audit programs, coordinate internal audits, and provide consultancy on quality and regulatory compliance to internal and external stakeholders.
The Senior Site Contracts Lead oversees the end-to-end site contracting process for clinical trials, ensuring timely execution and compliance with project requirements. They provide leadership to the site contracts team, manage budgets, and collaborate with cross-functional stakeholders to mitigate risks and optimize contracting strategies.
The Investigator Payments Lead will manage the end-to-end life cycle of clinical site payments, ensuring timely and accurate processing from startup through study close. They will also provide oversight of vendor staff and troubleshoot complex payment issues to maintain site satisfaction and contractual compliance.
The Executive Director will lead a global organization responsible for investigator payment services, overseeing strategy, operational excellence, and digital transformation. They will partner with cross-functional teams to modernize financial systems and ensure accurate, timely payments to clinical research sites.
The Executive Director will lead a global organization responsible for investigator payment services, overseeing strategy, operational excellence, and digital transformation. They will partner with cross-functional teams to modernize financial ecosystems through automation and AI-driven solutions while ensuring site satisfaction and study execution.
The Clinical Trial Leader is accountable for the end-to-end set-up, execution, and delivery of assigned clinical trials within the client's pipeline. They provide leadership to the trial team, manage stakeholder interactions, and ensure compliance with regulatory requirements and trial milestones.
Manage the full lifecycle of clinical site payment administration, including protocol schedules, budget configurations, and payment triggers. Troubleshoot payment failures and provide oversight of vendors to ensure adherence to contractual terms and operational standards.
The Global Study Manager provides operational leadership throughout the clinical trial lifecycle, overseeing study management, site management, and vendor deliverables. They are responsible for driving study execution, managing budgets, and ensuring compliance with quality standards and regulatory requirements.
The Site Payments Associate is responsible for reviewing and interpreting clinical payment documents to ensure accurate and timely site payments. They will also configure payment systems, resolve payment ambiguities, and collaborate with business partners to track documentation.
The Senior Regulatory Affairs Consultant manages regulatory activities and deliverables associated with Clinical Trial Applications (CTA) submissions. They also lead study teams and collaborate with global partners to ensure high-quality, compliant submission packages are delivered on time.
The Regulatory Affairs Consultant manages clinical trial application (CTA) submissions and associated documentation while partnering with study teams. They also lead meetings to advocate for deliverable timelines and ensure high-quality, compliant global submission delivery.
The Clinical Operations Manager is responsible for overseeing project delivery, ensuring adherence to budgets and timelines, and managing project documentation. They also lead performance management, staff development, and client relations to ensure high-quality clinical trial outcomes.
The role provides end-to-end regulatory affairs support for pharmaceutical partnerships, including documentation management, submission execution, and compliance. It involves serving as a key regulatory interface to ensure operational excellence across clinical and post-approval activities.
The Study Operations Manager oversees clinical trial activities from startup through conduct and close, providing leadership and strategic planning to ensure operational delivery. They are responsible for managing country-level plans, vendor oversight, and coordinating with internal and external stakeholders to ensure timely study execution.
The Global Study Manager II provides operational leadership throughout the clinical trial lifecycle, ensuring the execution of study management, site management, and vendor deliverables. They are responsible for driving study strategy, managing budgets, and overseeing cross-functional teams to ensure high-quality data delivery and inspection readiness.
The Documentation Specialist will develop and manage high-quality clinical and regulatory documents, including protocols and trial reports, within electronic systems. They will also coordinate review cycles, facilitate project meetings, and ensure compliance with quality standards throughout the document lifecycle.
The Medical Writer II is responsible for developing and managing high-quality clinical and regulatory documents, including protocols and clinical trial reports. They will coordinate review cycles, ensure document compliance, and collaborate with cross-functional teams to meet project timelines.
The Senior Medical Writer will develop and manage high-quality clinical and regulatory documents, including protocols and clinical trial reports. They will also coordinate review cycles, ensure compliance with project timelines, and facilitate cross-functional team alignment.
The Investigator Contracts Lead II manages direct site-facing contract and budget negotiations while overseeing other contracting professionals on assigned studies. They act as a single point of contact for complex contracting strategies and collaborate with Legal, Finance, and pCRO teams to ensure clinical trial execution.
The Director of AI Platforms will lead the engineering team responsible for the shared technical foundation that powers AI delivery across the enterprise. This role involves defining platform strategy, ensuring infrastructure reliability, managing vendor relationships, and collaborating with cross-functional teams to support scalable AI solutions.
The FSP Program Lead is responsible for the direct line management of clinical operations staff and the oversight of client accounts to ensure high-quality deliverables. They serve as the central point of contact for client governance, resource planning, and the implementation of strategic clinical trial solutions.
The Global Study Manager II provides operational leadership throughout the clinical trial lifecycle, overseeing study management, site execution, and vendor deliverables. They are responsible for setting operational strategies, managing budgets, and ensuring compliance with global standards and inspection readiness.
Monitor clinical trial sites through on-site and remote visits while maintaining strong relationships with investigators and site staff. Ensure study integrity by managing documentation, systems updates, and implementing corrective actions to keep sites audit-ready.
The Data Surveillance Analyst is responsible for analyzing scientific and operational data to support the Data Surveillance process and reviewing project-specific Quality Tolerance Limits. They also configure surveillance technologies and collaborate with project teams to identify and escalate data quality signals.
The Study Operations Manager oversees clinical trial activities from startup through conduct and closeout, ensuring operational delivery and adherence to project plans. They lead local study teams, manage vendor relationships, and coordinate with regulatory bodies to ensure compliance and timely milestone achievement.
The Business Intelligence Manager will drive strategic analytics and reporting solutions to support clinical research operations and leadership decision-making. Responsibilities include developing Power BI dashboards, ensuring data governance, and leading continuous improvement initiatives across the organization.
The Clinical Research Associate will monitor clinical trial sites through on-site and remote visits while maintaining strong relationships with investigators and site staff. They are responsible for managing study documentation, ensuring compliance, and implementing corrective actions to maintain study integrity.
The role involves drafting, negotiating, and implementing global investigative site budgets and contracts while ensuring compliance with clinical trial standards. You will collaborate with internal and external stakeholders to manage study start-up activities and drive process improvements.
The General Manager will lead the strategy, performance, and growth of a significant Functional Service Provider (FSP) customer account. They are responsible for ensuring operational excellence, financial profitability, and strengthening executive-level client relationships.
The Senior Medical Writer will author, review, and manage clinical and regulatory documents to support global drug development programs. They will also coordinate cross-functional reviews and serve as the primary medical writing representative on project teams.
The Senior Project Leader will manage day-to-day operations for global clinical trials, ensuring projects are delivered on time, within budget, and to high quality standards. They will provide leadership to project teams and coordinate activities to meet client expectations and advance clinical research.
The Global Site Start-up Lead is responsible for the global execution and strategy of clinical trial site activation, ensuring compliance with SOPs and regulatory standards. They act as a subject matter expert, overseeing CRO performance and managing cross-functional team interactions to resolve site-related challenges.
The Senior Medical Writer will create and manage clinical documents such as CTRs, CTPs, and submission reports within a dedicated sponsor-aligned environment. They are responsible for document management, quality control, and ensuring compliance with regulatory standards and sponsor SOPs.
The Regulatory Project Manager will partner with Global Regulatory Leads to drive globally aligned regulatory plans and manage complex development and registration programs. They are responsible for facilitating cross-functional team meetings, ensuring regulatory milestones are met, and maintaining clear communication across global and regional teams.
The Site Activation Partner manages operational activities from study start-up to close-out to ensure compliance with clinical trial timelines and regulatory standards. They coordinate essential document management, support site initiation, and maintain clinical trial systems to track site performance.
The Senior Medical Writer is responsible for authoring, reviewing, and finalizing complex clinical documents for regulatory submissions while ensuring compliance with SOPs and guidelines. They also act as a project lead, managing timelines, coordinating team reviews, and maintaining collaborative relationships with clients.
The Director will lead the adoption and integration of AI capabilities across the organization by translating complex technical concepts into actionable guidance for non-technical stakeholders. They will manage a team responsible for AI education, strategic communications, and building organizational fluency in AI-driven transformation.
Lead the team responsible for building rapid-turn AI solutions, including RPA and AI agents, while balancing direct delivery with citizen-developer enablement. Manage a portfolio of automation initiatives, establish governance standards, and foster relationships with business unit leaders to drive strategic value.
The Senior Manager is responsible for overseeing all vendor-related operational deliverables throughout the clinical trial lifecycle, including budget management and quality compliance. They act as a primary point of contact for vendor performance, risk mitigation, and cross-functional collaboration to ensure site readiness and trial success.
Oversee and manage the delivery of User Acceptance Testing (UAT) for eClinical vendor systems including IRT, eCOA, and ePRO. Collaborate with cross-functional teams and sponsors to ensure technology solutions meet project requirements and regulatory standards.
Develop CMC regulatory strategies and manage the preparation of marketing authorization applications for new drug development. Coordinate with clients and regulatory authorities (PMDA) to handle inquiries and ensure product approval and change management.
The consultant manages regulatory activities and deliverables associated with Clinical Trial Application (CTA) submissions. They lead meetings to align timelines and ensure submissions comply with industry and agency guidelines.
Oversee the conduct of clinical trials at investigator sites to ensure compliance with monitoring plans, GCP, and regulatory standards. Manage site activities from activation through database lock, including monitoring adverse events and maintaining Trial Master File documentation.
The role involves designing and coding R and SQL programs to analyze real-world evidence data from sources like Optum and Flatiron. Responsibilities include cleaning data, implementing epidemiological methodologies, and developing dashboards to communicate findings.
Monitor clinical trial sites through on-site and remote visits while maintaining strong relationships with investigators. Ensure study integrity by managing documentation and keeping sites audit- and inspection-ready.
Provide expert consultation on RTSM and DHT study design, translating complex requirements into functional project specifications. Manage the delivery of project deliverables while collaborating with stakeholders and external clients to mitigate risks.
The CRA is responsible for conducting various site visits, including qualification and initiation, to ensure study integrity and patient safety. They act as the primary point of contact for clinical sites, managing quality and delivery from identification through close-out.
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.
Lead global clinical trials in Neurology, Psychiatry, or Rare Disease for biotech clients. Manage day-to-day operations to ensure on-time delivery within budget and high quality standards.
Lead global clinical trials for biotech clients focusing on Metabolic, GLP-1, and Obesity therapeutics. Manage day-to-day operations to ensure on-time delivery within budget and high-quality standards.
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 strategic project leadership.
The role involves managing site and supervisory activities for assigned oncology studies for a single dedicated client. Responsibilities include monitoring sites and mentoring junior Clinical Research Associates.
The role involves managing site contracts and providing administrative support for contract-related activities. It ensures compliance and coordination between the site and contracting parties.
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 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.
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.
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 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 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.
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.
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.
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 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.
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.
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.
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.
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 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 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.
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.
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 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.
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.
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.
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.
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 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.
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.
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.
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.
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 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.
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 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 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.
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.
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 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.
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.
