Oversees domestic and global Phase I clinical projects, managing scope, schedule, cost, and quality to meet client expectations. Leads cross-functional teams and handles risk assurance, regulatory documentation, and potential line management duties.
Fortrea
141 Remote Job Openings at Fortrea
The Clinical Project Manager II is responsible for the operational strategy, budget, and timeline of Phase I clinical trials. They lead high-performing matrixed teams to ensure project delivery meets quality standards and customer needs.
The role is responsible for the oversight and accountability of Regulatory Authority, IRB/EC, and Third Body submissions for designated projects. This includes managing submission strategies, timelines, and ensuring compliance with applicable regulations and client requests.
Lead the end-to-end delivery of Healthy Volunteers and Patient Clinical Pharmacology projects while managing sponsor relationships and project budgets. Ensure quality, compliance, and audit readiness according to SOPs and ICH/GCP standards within a matrix environment.
Senior Clinical Project Manager or Project Manager II - Oncology
Fortrea
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Full Time
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3 days ago
Fortrea
The Senior Project Manager oversees domestic and global oncology projects, managing teams, budgets, risks, and stakeholder communications to ensure operational excellence. They are also responsible for regulatory documentation, line management of staff, and supporting business development efforts.
The Site Navigator II coordinates site-level activities during the start-up phase of clinical studies, serving as the primary contact for investigative sites. Key duties include managing regulatory compliance, performing site selection, and negotiating contracts and budgets to ensure efficient site activation.
Workflow Manager, Pharmacovigilance Operations (Specialist II, PSS) US Remote
Fortrea
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Full Time
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4 days ago
Fortrea
The Workflow Manager oversees end-to-end safety case workflows, ensuring adverse events are processed and tracked according to regulatory timelines. They coordinate activities across safety operations and monitor compliance metrics to ensure high-quality service delivery.
Lead and support site activation teams to ensure clinical studies are activated efficiently and ready to enroll participants on time. Partner with Clinical Operations to improve timelines and develop country-specific Informed Consent Forms.
Lead and oversee site budget and contract activities across assigned countries to ensure timely clinical trial start-up. Negotiate Clinical Trial Agreements (CTAs) and manage budgets while acting as an escalation point for complex discussions.
The Site SSU Lead is responsible for leading site activation teams and shaping study start-up strategies to ensure clinical trials are ready to enroll participants on time. This includes developing country-specific Informed Consent Forms and using data-driven insights to optimize performance and timelines.
Lead and oversee site budget and contract activities across assigned countries to ensure timely clinical trial start-up. Negotiate Clinical Trial Agreements (CTAs) and manage budgets while collaborating with study teams and sponsors.
The specialist coordinates site start-up activities and manages essential regulatory documents for clinical trials. They serve as the primary contact for investigative sites and ensure compliance with ICH/GCP guidelines and sponsor specifications.
Lead and empower site activation teams to drive the successful planning and activation of global clinical trials. Develop data-driven forecasting models and optimize study start-up metrics to accelerate study timelines.
Manage and negotiate site budgets and Clinical Trial Agreements to ensure timely study startup and contract execution. Act as an escalation point for global budget issues and develop processes to improve service delivery.
The specialist is responsible for preparing, negotiating, and managing site agreements and confidentiality contracts for clinical trials. They ensure compliance with SOPs and regulatory guidelines while collaborating with legal and project management teams.
Sponsor Dedicated Site Budget & Contract Lead based in Switzerlandd
Fortrea
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Full Time
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4 days ago
Fortrea
Lead the development, negotiation, and execution of Clinical Trial Agreements and site budgets for assigned countries. Oversee budget setup and serve as an escalation point to ensure sites achieve 'Ready to Enroll' status on schedule.
Lead and empower site activation teams to drive the successful planning and activation of clinical trials across multiple countries. Manage EU-CTR submissions, oversee document collection, and optimize study start-up processes and SOPs.
The Project Manager is responsible for the operational strategy, budget, and timely delivery of clinical trials while maintaining quality and customer satisfaction. They lead high-performing teams in a matrixed environment to manage the end-to-end project lifecycle from scope to execution.
The Clinical Team Lead owns the clinical delivery of research trials, acting as the Clinical Project Manager to ensure trials meet contractual and budgetary requirements. They are responsible for driving project performance, managing clinical vendors, and leading high-performing project teams in a matrix environment.
Lead clinical data management activities from study start-up to database lock, ensuring deliverables meet quality expectations and timelines. Act as a subject matter expert for sponsors and provide guidance, mentoring, and training to junior data management staff.
Sponsor Dedicated Site Budget & Contract Specialist based in Switzerland
Fortrea
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Full Time
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5 days ago
Fortrea
Negotiate and manage site agreements, confidentiality agreements, and letters of indemnification for clinical trials. Ensure compliance with SOPs and regulatory guidelines while collaborating with legal and project management teams.
The specialist is responsible for executing central monitoring activities at the site, subject, and study levels using informatics platforms. They identify risks, recommend mitigations, and communicate findings to the study team to ensure compliance.
Manage the development, negotiation, and execution of clinical trial agreements and site budgets to ensure timely study startup. Act as an escalation point for global budget issues and leverage industry tools to align with fair market value guidance.
Clinical Research Associate I - Full Service Operations Model - Italy
Fortrea
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Full Time
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5 days ago
Fortrea
Responsible for site monitoring and management of clinical studies, including routine monitoring, closeout visits, and ensuring data integrity. The role involves liaising with vendors, managing study files, and ensuring adherence to regulatory guidelines and project plans.
Coordinate site start-up activities and manage essential regulatory documents for clinical trials. Serve as the primary contact for investigative sites to ensure compliance with ICH/GCP guidelines and sponsor specifications.
Lead and empower site activation teams to drive the successful planning and activation of clinical trials across multiple countries. Manage EU-CTR submissions, document oversight, and the development of new study start-up processes and SOPs.
The specialist is responsible for preparing, negotiating, and managing site agreements and confidentiality contracts for clinical trials. They ensure compliance with SOPs and regulatory guidelines while collaborating with legal and project management teams.
Manage the development, negotiation, and execution of clinical trial agreements and site budgets to ensure timely study startup. Act as an escalation point for global budget issues and leverage industry data to align with fair market value guidance.
Lead clinical data management activities from study start-up to database lock, ensuring deliverables meet quality expectations, timelines, and budgets. Provide leadership, mentoring, and technical guidance to junior staff while acting as the primary subject matter expert for sponsors.
Lead the Data Management department by ensuring high-quality delivery of services in compliance with protocols and GCP. Manage staff development, departmental budgets, and strategic client relationships while supporting business development activities.
The TMF Lead II manages the completeness and accuracy of the Trial Master File throughout the clinical trial lifecycle. They drive inspection readiness, monitor TMF health via KPIs, and provide technical expertise on eTMF systems.
Manage the development, negotiation, and execution of clinical trial agreements and site budgets for the EMEA region. Act as an escalation point to ensure timely contract execution and alignment with study startup forecasts.
Lead and mentor site activation teams to drive the successful planning and activation of global clinical trials. Partner with Clinical Operations to optimize study start-up metrics and implement data-driven forecasting models.
Lead clinical data management activities from study start-up to database lock, ensuring deliverables meet quality expectations and timelines. Manage direct relationships with sponsors and provide leadership and mentorship to the internal data management study team.
Director/Senior Director, Participant Recruitment & Engagement
Fortrea
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Full Time
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7 days ago
Fortrea
Lead the strategic development and execution of participant recruitment, engagement, and retention initiatives for clinical pharmacology services. Optimize multi-channel acquisition campaigns and leverage analytics to improve participant conversion and study completion rates.
Lead clinical data management activities from study start-up to database lock, ensuring deliverables meet quality expectations, timelines, and budgets. Act as the subject matter expert in client-facing meetings and provide guidance and mentoring to junior data management staff.
Responsible for developing and negotiating Clinical Trial Agreements (CTAs) and site budgets to ensure timely study start-up. This includes liaising with legal departments, managing contract tracking databases, and ensuring compliance with global SOPs.
Assist with Clinical Safety and PSS operations, focusing on the processing and submission of expedited and periodic safety reports. Responsibilities include data entry, writing patient narratives, and maintaining adverse event tracking systems in compliance with regulatory requirements.
The role involves monitoring clinical trials through site visits to ensure protocol and GCP compliance. Responsibilities include managing investigational sites, verifying clinical data accuracy, and providing training to site staff.
CRA 1/2 & Sr. CRAs - Oncology & General Medicine, French Speaking Desired- Canada
Fortrea
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Full Time
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12 days ago
Fortrea
Responsible for all aspects of clinical site monitoring, including routine visits, close-outs, and site management. Ensures data integrity, patient protection, and adherence to study protocols and regulatory requirements.
CRAs & Sr. CRAs - Radiopharmaceutical Therapies - Remote US
Fortrea
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Full Time
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12 days ago
Fortrea
Responsible for all aspects of study site monitoring, including routine monitoring, close-out visits, and maintenance of study files. Ensures the protection of study patients and the integrity of data submitted on Case Report Forms.
The role involves acting as the primary contact for clinical trial sites and managing the site lifecycle from start-up to close-out. Responsibilities include conducting monitoring visits and ensuring compliance with study protocols and regulatory requirements.
Investigator Grants Manager / Clinical Trial Costing Manager – Brazil (Remote)
Fortrea
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Full Time
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13 days ago
Fortrea
Develop and manage Investigator Grant Estimates and detailed study budgets for clinical trial proposals. Partner with stakeholders to create competitive costing strategies and drive process improvements in grants management.
FSP Sr. Clinical Research Associate II - NYC Metro or PHL - Onc
Fortrea
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Full Time
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14 days ago
Fortrea
Responsible for all aspects of clinical site monitoring, including initiation, routine visits, and close-out of oncology trials. Ensures data integrity, patient safety, and adherence to study protocols and regulatory requirements.
Senior Director, Commercial and Marketing Technology Platforms
Fortrea
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Full Time
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14 days ago
Fortrea
Lead the strategy and evolution of commercial and marketing technology platforms, including CRM and marketing automation. Manage a high-performing team of product managers and engineers to drive operational efficiency and data-driven decision-making.
Responsible for all aspects of study site monitoring, including routine monitoring, close-out visits, and site management. Ensures the protection of study participants and the integrity of clinical trial data through rigorous verification and reporting.
Responsible for site management and monitoring of clinical trials, including conducting initiation, routine, and close-out visits. Ensures data integrity, subject protection, and adherence to ICH GCP guidelines and sponsor requirements.
Responsible for clinical site monitoring, management, and ensuring adherence to regulatory guidelines and project plans. Acts as a leader for limited-scope projects and coordinates local project activities including site initiation and closeout.
Lead the design, governance, and enhancement of the Workday security framework to ensure secure and compliant access to enterprise data. Partner with HR, Finance, and IT teams to manage security policies, conduct audits, and resolve security-related incidents.
Support the acquisition, review, and integration of external clinical trial data to ensure integrity and quality. Coordinate with internal teams and external vendors to resolve data discrepancies and meet study deliverables.
Manage the end-to-end proposal process, including the development of budgets, timelines, and high-quality written responses to RFIs and RFPs. Collaborate with internal experts, external vendors, and global stakeholders to deliver competitive business proposals.
Plan and oversee programming activities for studies, including resource estimation and timeline management. Develop and maintain SAS programs to create SDTM and ADaM datasets and TFLs while mentoring junior programmers.
Serve as a subject matter expert in Real World Data analytics to support the analysis of large healthcare databases for pharmaceutical compounds. Collaborate with cross-functional stakeholders to contribute to study design, programming, and the interpretation of study results.
The Clinical Trial Manager provides operational oversight of clinical research trials from site identification through database lock. This includes managing project scope, timelines, budgets, and ensuring compliance with regulatory requirements.
Monitoring Excellence Academy - OMEA - Oncology / CAR T & Gen Meds - CRA 1
Fortrea
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Full Time
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19 days ago
Fortrea
Responsible for all aspects of clinical study site monitoring, including routine visits, close-outs, and site management. Ensures data integrity, patient protection, and adherence to protocol and regulatory requirements.
The Project Coordinator provides operational support to the Project Lead by managing project schedules, budgets, and risk identification tools. They facilitate team communication and ensure quality compliance and TMF documentation are maintained throughout the study.
Sr. Manager, Centralized Monitoring, Risk-Based Monitoring (RBM) & Risk-Based Quality Management (RBQM)
Fortrea
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Full Time
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19 days ago
Fortrea
Oversee site, regional, and study-level centralized and risk-based monitoring activities to identify risks and safety concerns. Partner with clinical trial leads and sponsors to drive data-driven monitoring strategies and ensure regulatory compliance.
Drive revenue growth by managing strategic biotech accounts and cultivating relationships with key decision-makers. Lead the development of account plans, pricing, and proposals while collaborating across business units to identify multi-unit opportunities.
Lead and execute global account strategies for high-impact pharmaceutical portfolios to drive revenue growth and market share. Act as the primary commercial negotiator and trusted interface for senior client decision-makers across multiple business units.
Provide medical leadership and oversight for rheumatology clinical trials across all phases of development. Act as a key medical representative for client interactions, business development, and the execution of medical strategies.
Manager, Centralized, Risk-Based Monitoring & Risk-Based Quality Management (RBQM)
Fortrea
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Full Time
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21 days ago
Fortrea
Oversee site, regional, and study-level centralized and risk-based monitoring activities to identify risks and ensure timely resolution. Partner with clinical leads and sponsors to drive risk assessments, analytics, and compliance with regulatory requirements.
Executive Director, Clinical Platforms & Product Development
Fortrea
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Full Time
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22 days ago
Fortrea
Lead the strategic definition, development, and operationalization of Fortrea's clinical platforms ecosystem to enhance clinical trial delivery. Drive the end-to-end product lifecycle while managing global engineering teams, vendor partnerships, and commercial enablement activities.
Support the end-to-end acquisition and quality of third-party clinical trial data while ensuring compliance and audit readiness. Collaborate with external vendors and cross-functional teams to resolve risks and optimize data integration processes.
Director of Product Engineering - Clinical Data Management / EDC
Fortrea
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Full Time
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24 days ago
Fortrea
Lead the overall product lifecycle and strategy for clinical data management software within the life sciences sector. Bridge the gap between technology and business to deliver innovative, compliant products that meet client needs and strategic goals.
Responsible for managing the end-to-end processing of adverse event reports from clinical trials and post-marketing settings. This includes data entry, MedDRA coding, writing patient narratives, and ensuring timely submission of expedited reports to regulatory agencies.
The role involves managing external data oversight, including acquisition and reconciliation from third-party vendors for oncology studies. You will act as a key liaison between clients and vendors to ensure data integrity and adherence to study timelines.
Responsible for site management and monitoring of clinical trials, including conducting initiation, routine, and close-out visits. Ensures subject protection, data integrity, and adherence to ICH GCP guidelines and sponsor requirements.
Responsible for site management and monitoring of clinical trials, including conducting initiation, routine, and close-out visits. Ensures data integrity, subject protection, and adherence to SOPs and regulatory requirements.
The role involves building and maintaining clinical study site budgets and negotiating rate cards for clinical trial agreements. You will partner with internal teams and site payment departments to ensure compatibility with payment systems and EDC requirements.
Oversee the financial and operational delivery of a clinical study portfolio to ensure on-time, high-quality, and budget-compliant execution. Drive business growth by developing client relationships and contributing to innovative clinical delivery strategies and proposals.
The Site Engagement Lead manages the clinical delivery of research trials, acting as the Clinical Project Manager to ensure trials meet contractual and budgetary requirements. They are responsible for driving project performance, managing site operations, and leading high-performing clinical project teams.
Senior Delivery Director - Immunology and Respiratory Expertise
Fortrea
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Full Time
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a month ago
Fortrea
Oversee the financial and operational delivery of a clinical study portfolio to ensure quality, budget adherence, and timely execution. Drive business growth by contributing to new opportunities and maintaining senior-level client relationships.
Senior Clinical Data Manager - sponsor dedicated - oncology
Fortrea
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Full Time
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a month ago
Fortrea
Lead the full cycle of Clinical Data Management for oncology studies, serving as the primary point of contact for sponsors. Responsibilities include creating eCRFs, cleaning data, and managing vendor contracts and budgets.
Oversee the financial and operational delivery of a clinical study portfolio to ensure quality, budget adherence, and timely execution. Drive business growth by developing client relationships and contributing to innovative clinical delivery strategies and proposals.
Oversee and manage Regulatory Authority, IRB/EC, and Third Body submissions to ensure timely project delivery and compliance. Provide regulatory expertise to project teams and clients while managing submission timelines and risk escalation.
Lead and develop a team of Commercial analysts to deliver high-quality reporting, dashboards, and data-driven insights. Drive process improvement, reporting standardization, and cross-functional partnerships to support business decision-making.
Senior Clinical Project Manager or Project Manager II - Respiratory, Diabetes/Weight loss, Immunology or MASH
Fortrea
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Full Time
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a month ago
Fortrea
Oversee domestic and global clinical projects, managing teams, budgets, risks, and schedules to ensure operational delivery. Serve as the primary client contact and provide mentorship and line management to project staff.
Lead and oversee clinical trial start-up activities, including site identification, regulatory submissions, and contract negotiations. Perform advanced in-house CRA duties such as document review, data validation, and TMF maintenance to ensure audit readiness.
The Senior Project Manager oversees domestic and global clinical projects, managing scope, cost, quality, and stakeholder expectations. They are also responsible for leading project teams, ensuring regulatory data accuracy, and potentially handling line management and business development.
Provide medical safety expertise for clinical trials and post-marketing periods, including the medical review of adverse events. Responsible for preparing aggregate reports and performing signal detection and evaluation for global regulatory agencies.
The role involves negotiating and managing site agreements, budgets, and confidentiality contracts for clinical research studies. It also requires partnering with internal teams to improve budget metrics and ensure compatibility with payment systems.
Provide medical leadership and oversight for ophthalmology clinical programs across all development phases, including medical monitoring and safety review. Act as a primary client-facing representative to support business development and shape clinical strategies for proposals.
Coordinates site-level activities during the start-up phase of clinical studies, serving as the primary contact for investigative sites. Ensures regulatory compliance, manages site activation, and handles contract and budget negotiations.
Manage patient safety operations and the adverse events process for specific projects, ensuring compliant reporting to regulatory agencies. Provide leadership in harmonizing global processes, overseeing safety database entry, and preparing pharmacovigilance reports.
Oversee domestic and global clinical projects focusing on cell and gene therapy, managing scope, cost, quality, and risk. Act as the primary client contact and lead cross-functional teams to ensure operational excellence and regulatory compliance.
The role involves managing and specializing in external data within an FSP framework. The specialist will likely oversee data quality and integration from external sources.
Coordinates site-level activities during the start-up phase of clinical studies, serving as the primary contact for investigative sites. Ensures regulatory compliance, manages essential documents, and facilitates site activation through collaboration with sponsors and CROs.
The Clinical Trial Manager provides operational oversight of clinical research trials from site identification through database lock. This includes managing project scope, budgets, regulatory submissions, and ensuring compliance with professional standards and SOPs.
Manage complex clinical projects and ensure site monitoring adheres to SOPs, ICH Guidelines, and GCP. Lead process improvement initiatives and mentor new team members on trip report review and quality checks.
Support the delivery and logistics of clinical and ancillary supplies for assigned studies, including label review and country translations. Coordinate importation processes, manage vendor activities, and liaise with project teams to ensure smooth supply transportation.
Lead and oversee local laboratory data activities for clinical studies, ensuring accurate and compliant data delivery from startup to database lock. Collaborate with CROs, vendors, and internal cross-functional teams to maintain data standards and improve processes.
The Site Start-Up Specialist coordinates site activation activities and manages essential regulatory documents for clinical trials. They serve as the primary contact for investigative sites to ensure compliance with ICH/GCP guidelines and sponsor specifications.
The specialist is responsible for preparing, negotiating, and managing site agreements and confidentiality agreements for clinical trials. They ensure compliance with SOPs and regulatory guidelines while collaborating with legal and project management teams.
The role involves executing change management activities and translating strategies into practical delivery plans for Clinical Data Management transformation initiatives. Key duties include stakeholder mapping, coordinating engagement activities, and monitoring change adoption outcomes.
The Clinical Team Lead owns the clinical delivery of research trials, functioning as the Clinical Project Manager within the core project team. They are responsible for managing project scope, timelines, budgets, and site management while ensuring operational excellence and client satisfaction.
Responsible for comprehensive site monitoring and management of complex cardiac and medical device clinical studies. This includes conducting initiation and closeout visits, ensuring data integrity, and overseeing regulatory compliance at the site level.
Responsible for all aspects of clinical site monitoring, management, and closeout in accordance with SOPs and regulatory guidelines. Acts as a lead monitor or local project coordinator, ensuring data integrity and patient protection across cardiac and medical device studies.
Manage the planning, execution, and completion of oncology clinical trials while ensuring timelines, budgets, and quality standards are met. Serve as the primary contact for clinical operations teams and vendors while ensuring compliance with German EU regulatory requirements.
Responsible for all aspects of study site monitoring, including routine monitoring, close-out visits, and maintenance of study files. Ensures the protection of study patients and the integrity of data submitted via Case Report Forms.
Conduct site monitoring visits including initiation, routine, and close-out while ensuring patient safety and protocol compliance. Manage site documentation, source data verification, and investigational product accountability to maintain high data quality.
Principal Consultant, Senior Director - RWE, Market Access, Regulatory (Europe)
Fortrea
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Full Time
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2 months ago
Fortrea
Lead business development efforts and manage key client relationships to drive financial objectives. Oversee the delivery of strategic consulting engagements across RWE, HEOR, and regulatory strategy to demonstrate product value.
Senior CRA II Sponsor Dedicated based in Munich, Düsseldorf or Berlin regions
Fortrea
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Full Time
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2 months ago
Fortrea
Act as the primary contact for clinical trial sites, managing the full site lifecycle from start-up to close-out. Ensure study compliance with ICH-GCP and local regulations while overseeing data quality and site performance.
Clinical Research Associate, sponsor-dedicated Home Office - Deutschland
Fortrea
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Full Time
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2 months ago
Fortrea
Manage all aspects of site management from selection to close-out for complex Phase I-III clinical trials. Provide support through training and mentoring new employees and act as a subject matter expert in customer-specific working groups.
The Clinical Team Lead is responsible for the clinical delivery of research trials, acting as the Clinical Project Manager to ensure trials meet contractual and budgetary requirements. They oversee site management, subject recruitment, and lead the clinical project strategy while managing risks and quality.
Executive Director, Clinical Pharmacology Services Quality Assurance (United States or United Kingdom)
Fortrea
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Full Time
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2 months ago
Fortrea
Provide executive leadership for Quality Assurance and Regulatory Compliance within the Clinical Pharmacology Services business unit. Lead the design and implementation of audit, inspection readiness, and quality oversight programs across global clinical pharmacology units and GMP pharmacies.
Executive Director, Clinical Pharmacology Services Quality Assurance (United States or United Kingdom)
Fortrea
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Full Time
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2 months ago
Fortrea
Provide executive leadership for Quality Assurance and Regulatory Compliance within the Clinical Pharmacology Services business unit. Lead the design and implementation of audit and inspection readiness programs across global clinical pharmacology units and GMP pharmacies.
The Senior CRA is responsible for comprehensive site monitoring and management, ensuring clinical studies adhere to SOPs and regulatory guidelines. Key duties include conducting initiation and closeout visits, managing study files, and overseeing data integrity and patient safety.
Manage regional pharmacovigilance operations and lead a team of direct and indirect reports to ensure high-quality safety services. Oversee regulatory compliance, project budgets, and the timely reporting of adverse events to clients and authorities.
The role involves designing, configuring, and deploying Workday Procure-to-Pay solutions to optimize procurement and payment processes globally. The manager will partner with Finance and Procurement teams to deliver scalable solutions and manage system updates during Workday releases.
Manage clinical trial start-up activities, including site identification, feasibility, and regulatory submissions to Ethics Committees and Regulatory Authorities. Perform in-house CRA tasks such as document review, data validation, and TMF maintenance to ensure inspection readiness.
Responsible for all aspects of study site monitoring, including routine visits, close-outs, and site management for oncology clinical trials. Ensures data integrity, patient protection, and adherence to protocol and regulatory requirements.
Sponsor dedicated Senior Clinical Research Associate (w/m/d) - home based
Fortrea
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Full Time
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2 months ago
Fortrea
Manage all aspects of clinical site management from selection to close-out for Phase I-III studies. Provide mentoring and training for new employees and serve as a subject matter expert in customer-specific working groups.
Lead data management activities from study start-up to database lock, ensuring deliverables meet quality expectations, timelines, and budgets. Act as a subject matter expert for sponsors and provide guidance, mentoring, and training to junior data management staff.
Responsible for all aspects of study site monitoring, including routine visits, close-outs, and site management for oncology clinical trials. Ensures data integrity, patient protection, and adherence to protocol and regulatory requirements.
Responsible for all aspects of clinical site monitoring, including routine visits, close-outs, and site management. Ensures patient protection, data integrity, and adherence to study protocols and regulatory requirements.
Lead the end-to-end delivery of Healthy Volunteers and Patient Clinical Pharmacology projects, managing scope, timelines, and budgets. Act as the primary contact for sponsors while ensuring quality, compliance, and adherence to ICH/GCP standards.
Lead and oversee site start-up and activation activities while serving as the primary contact for investigative sites. Manage regulatory submissions, contract negotiations, and mentor junior Site Navigators to ensure study efficiency and compliance.
Manage the end-to-end processing and submission of adverse event reports and pharmacovigilance documents to regulatory agencies and clients. Provide leadership on safety projects, ensure global regulatory compliance, and support the training of junior safety staff.
Design and implement statistical strategies and analysis plans for clinical trials across various therapeutic areas. Perform SAS programming to generate study reports and provide expert guidance on methodology and sample size calculations.
Conduct site monitoring visits and ensure compliance with protocols, SOPs, and regulations. Perform source data verification and manage SAE reporting to ensure patient safety and data quality.
Coordinates site-level activities during the start-up phase of clinical studies, serving as the primary contact for investigative sites. Ensures regulatory compliance, manages site activation milestones, and handles contract and budget negotiations.
Manage clinical trial sites by performing monitoring visits and ensuring patient safety and protocol adherence. Maintain data integrity through source data verification and oversee regulatory documentation and investigational product accountability.
Responsible for the implementation, configuration, and support of safety systems to ensure high-quality service for internal and external clients. This includes conducting data extractions, managing system migrations, and collaborating with stakeholders to deliver business requirements.
Lead and manage clinical sites across complex indications while building relationships with investigators. Ensure patient safety and data integrity are maintained throughout innovative first-in-class studies.
Prepares, negotiates, and executes site agreements and confidentiality contracts for sponsors. Maintains contract tracking systems and ensures all activities comply with departmental SOPs and corporate requirements.
Support the management of clinical trial sites by conducting monitoring visits and ensuring compliance with SOPs and ICH-GCP guidelines. Perform source data verification and maintain essential trial documentation to ensure data quality and inspection readiness.
The Senior Technical Designer leads eCRF design and database programming within the Medidata Rave EDC system for clinical trials. They are responsible for preparing specifications, performing quality control, and providing guidance to team members to ensure project consistency and compliance.
The Contract Analyst II will independently develop, review, and negotiate medium complexity agreements and change orders for strategic accounts. They will also work cross-functionally to resolve contract issues, ensure compliance, and mentor junior staff.
The Senior Clinical Data Manager provides leadership for assigned projects, ensuring global accountability and effective management of CDM deliverables. They oversee vendor performance, manage budgets, and ensure data quality compliance across complex clinical trial programs.
The CRA 2 is responsible for all aspects of study site monitoring, including routine visits, site management, and maintenance of study files. They ensure protocol adherence, data integrity, and the protection of study participants while managing serious adverse event reporting.
The Therapeutic Strategy Leader contributes to therapeutic area strategy and provides medical and scientific leadership to support business development and growth. They ensure the delivery of MedSci activities in compliance with regulatory standards while building strong relationships with clients and key opinion leaders.
The Hosting Architect will lead the enterprise transition from on-premises datacenters to a modern, automated Azure-based cloud platform. This role is responsible for designing hybrid architectures, governing cloud migrations, and implementing AI-driven operations to improve scalability and reduce costs.
Perform clinical site monitoring activities including initiation, routine visits, and close-outs to ensure data quality and patient safety. Manage clinical sites in accordance with project plans, SOPs, and regulatory requirements while collaborating with sponsors and investigators.
Senior or Principal Statistical Programmer - ONCOLOGY - Sponsor dedicated
Fortrea
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Full Time
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4 months ago
Fortrea
Develop and validate SAS programs for complex oncology clinical trials to support data analysis, reporting, and regulatory submissions. Collaborate on the creation of SDTM and ADaM datasets while ensuring compliance with industry standards and study timelines.
The Senior Director is responsible for driving business development, managing key client relationships, and overseeing strategic consulting engagements. They lead cross-functional teams to deliver expert solutions in areas such as clinical development, market access, and health economics.
The Senior Director is responsible for driving business development, managing key client relationships, and overseeing strategic consulting engagements. They lead cross-functional teams to deliver expert guidance on clinical development, market access, and value demonstration across product lifecycles.
The role involves leading and managing clinical trial sites across varied and complex indications while building trusted relationships with investigators and study teams. Key duties include ensuring paramount patient safety and data integrity, and actively contributing to innovative and first-in-class studies.
This role is responsible for the comprehensive coordination of site-level activities during the start-up phase of clinical studies, acting as the single point of contact for investigative sites to ensure smooth progression and regulatory compliance. Key duties include site activation, support, training, and collaboration between sponsors, CROs, and site staff, while protecting patient rights and safety.
This role coordinates comprehensive site-level activities from study start-up through maintenance, serving as the primary contact for investigative sites to ensure smooth progression and regulatory compliance. Responsibilities include overseeing site activation tasks, identifying and assessing research sites, managing essential document collection, and supporting ongoing site compliance and study team milestones.
Principal Statistical Programmer - Sponsor Dedicated, EMEA
Fortrea
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Full Time
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5 months ago
Fortrea
The role involves planning, executing, and overseeing all programming activities for complex studies, including resource estimation, budget adherence, and timeline management. Responsibilities also include overseeing SDTM, ADaM, and TLF development, performing senior reviews, and supporting submission activities.
The Senior Clinical Data Manager will lead studies and manage all data management deliverables from study start-up to database lock. This role includes client-facing activities, project documentation development, and mentoring junior staff.
