pune, Maharashtra, India · On-site
Job Overview: It is the responsibility of the post holder to provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner. The individual will be expected t…
Skills: Pharmacovigilance, Safety Writing, Quality Assurance, CAPA Management, Process Improvement
Paris, Ile-de-France, France · Hybrid
Join Our Team and Shape the Future of Clinical Research! At Fortrea, we are dedicated to streamlining clinical trials and ensuring compliance with global regulations. As a Site Budget & Contract Specialist, you will play…
Skills: Contract Negotiation, Budget Development, Clinical Research, ICH GCP Guidelines, Budget Tracking
pune, Maharashtra, India · On-site
Job Overview: • Assist with the overall Safety system implementation, support, configuration, and Migration related activities. • Responsible for providing this service to clients either as a support function to the clie…
Skills: Change Management, Customer Relationship Management (CRM), People Management, Vendor Management, Argus
Paris, Ile-de-France, France · Remote OK
Fortrea is recruiting! Our FSP department in Paris is looking for a Senior Clinical Research Associate II (SCRAII).Key Responsibilities:Monitor Clinical Trials - conduct site visits to ensure compliance with protocols, r…
Skills: Clinical Trial Monitoring, Site Management, Source Document Verification, Investigator Training, GCP Compliance
Leeds, England, United Kingdom · On-site
We exist to bring new medicines to life. What if your administrative support expertise could help us accelerate that journey? FORTREA IN LEEDS – WHERE MEDICAL BREAKTHROUGHS BEGIN At Fortrea, our world-class Clinical Rese…
Skills: Administrative Support, Clinical Trial Coordination, Data Collation, Quality Control, Microsoft Office
Mumbai City, Maharashtra, India · Hybrid
Job Overview: Scientific Writer with strong expertise in material science, analytical chemistry, and chemical principles (organic and inorganic) as applied to pharmaceutical formulation, manufacturing, and product lifecy…
Skills: CMC Documentation, Analytical Chemistry, Material Science, Pharmaceutical Manufacturing, Regulatory Affairs
Beijing, Beijing, China · Remote OK
Job Overview: Site Navigators play a critical role in the comprehensive coordination of site-level activities throughout the start-up phase of a clinical study and potentially through closeout activities as required. Ser…
Skills: Site Management, Regulatory Compliance, ICH/GCP Guidelines, Contract Negotiation, Budget Negotiation
Beijing, Beijing, China · On-site
Job Overview: Site monitoring and site management responsibility for clinical studies according to Company, and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines. Assures the implementation of project …
Skills: Site Monitoring, Site Management, Clinical Trial Process, Regulatory Guidelines, ICH GCP
Toronto, Ontario, Canada · Remote OK
We are currently seeking Experienced CRAs to lead and support our Full Service Outsourcing team supporting various sponsors. Oncology or Ophthalmology desired, seeking candidates on the East and West Coast of Canada. Fre…
Skills: Clinical Monitoring, Site Management, Oncology, Ophthalmology, CAR-T Therapy
Durham, California, United States · Remote OK
$105k–$145k/yr
We are currently seeking Experienced CRAs with Radiopharmaceutical therapeutic expertise to lead and support our Full Service Outsourcing team working with various sponsors. 1+ year of independent CRO/sponsor monitoring …
Skills: Clinical Monitoring, Site Management, Radiopharmaceutical Therapies, Case Report Forms, SAE Reporting
São Paulo, São Paulo, Brazil · On-site
Job Overview: Responsible for providing coordination and support of projects operated by the Adjudication Services department, to ensure smooth delivery and achievement of the objective that all adjudication events are p…
Skills: Adjudication Services, Case Processing, Quality Control, Medical Terminology, Good Clinical Practice (GCP)
Beijing, Beijing, China · Hybrid
Summary of Responsibilities: Site management responsibility for clinical studies according to Fortrea’s Standard Operating Procedures, ICH GCP Guidelines, applicable project plans and Sponsor requirements, including veri…
Skills: Site Monitoring, ICH GCP Guidelines, Clinical Trial Management, Source Data Verification, eCRF Review
Leeds, England, United Kingdom · On-site
What if you were the person clinical research teams relied on when project plans move into live clinic activity? Fortrea is one of the largest and longest‑established early‑stage clinical research organizations in the wo…
Skills: Clinical Trial Coordination, GCP Compliance, SOP Adherence, Study Documentation, Patient Journey Management
Shanghai, Shanghai, China · On-site
Job Overview: Primary contact with investigative site(s) during site start-up activities and maintenance with responsibility for collection of the required investigator and essential documents for a study, to ensure EC/I…
Skills: Site Start-up, Regulatory Submissions, ICH GCP, Document Management, IRB/IEC Coordination
Beijing, Beijing, China · Hybrid
Summary of Responsibilities: Site management responsibility for clinical studies according to Fortrea’s Standard Operating Procedures, ICH GCP Guidelines, applicable project plans and Sponsor requirements, including veri…
Skills: Site Monitoring, ICH GCP Guidelines, Source Data Verification, Clinical Trial Management, Regulatory Compliance
Shanghai, Shanghai, China · On-site
Job Overview: Primary contact with investigative site(s) during site start-up activities and maintenance with responsibility for collection of the required investigator and essential documents for a study, to ensure EC/I…
Skills: Site Start-up, Regulatory Submissions, ICH GCP, Clinical Research, Document Management
Shanghai, Shanghai, China · Hybrid
Summary of Responsibilities: Site management responsibility for clinical studies according to Fortrea’s Standard Operating Procedures, ICH GCP Guidelines, applicable project plans and Sponsor requirements, including veri…
Skills: Site Monitoring, ICH GCP Guidelines, Clinical Trial Management, Source Data Verification, eCRF Review
Beijing, Beijing, China · On-site
Job Overview: The Senior CRA I is responsible for site monitoring and site management. Responsibility for clinical studies according to Fortrea, and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines. T…
Skills: Site Monitoring, Site Management, Clinical Research, Regulatory Compliance, Case Report Forms
Shanghai, Shanghai, China · Remote OK
Job Overview: The Senior CRA I is responsible for site monitoring and site management. Responsibility for clinical studies according to Fortrea, and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines. T…
Skills: Site Monitoring, Site Management, Clinical Research, Regulatory Compliance, Case Report Forms
Istanbul, Istanbul, Turkey · Remote OK
Join Fortrea as a Senior Clinical Research Associate II in Türkiye within a sponsor-dedicated model, where you will work exclusively with a leading global biopharmaceutical partner. In this role, you will support the del…
Skills: Clinical Site Monitoring, Site Management, ICH-GCP, Oncology, Ophthalmology
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Responsible for implementing quality processes, CAPA management, and audit readiness across Pharmacovigilance and safety writing engagements. Acts as the process and quality expert for clients, driving proactive quality culture and process excellence.
Requires a degree in Medicine, Life Sciences, or a related field with at least 10 years of experience in the pharmaceutical or CRO industry. Must possess in-depth knowledge of GPV, FDA, and EU regulatory requirements along with Lean Six Sigma methodologies.
Job Overview:
It is the responsibility of the post holder to provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner. The individual will be expected to comply with the legal requirements of the Health & Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health & Safety Manual.
Summary of Responsibilities:
• Responsible for instituting and implementing a Quality process across designated PV and safety writing engagements.
• Accountable for quality, CAPA and compliance related deliverables for the assigned PV and Safety writing engagements.
• Drive implementation of best practices and process improvement for the assigned projects.
• Responsible for driving quality culture for the assigned projects.
• Drive CAPA management and audit readiness across projects.
• Identify quality trends and suggest corrective actions.
• Implement a feedback process and track implementation of feedback.
• Function as a Point of Contact for the delivery team for regulatory updates, quality assurance concepts, applicable procedures, practices, and conventions on the assigned projects.
• Act as the process and quality expert for the Client.
• Initiate and support initiatives for standardization of quality processes and process excellence across projects within the practice.
• Perform Analysis of data and if required, suggest strategies for process
improvement/excellence.
• Perform and Review of analysis of data performed and drive strategies for process improvement/excellence
Responsible for Driving Proactive Quality processes across the project.
• Oversee all aspects of quality reviews, metrics, analysis, outcomes, actions across the projects.
• Support internal audits of PV/ Safety writing projects as per the audit calendar and support as required for general systems and process audits.
• Oversee and conduct process reviews to ensure regulatory and client requirements and implement process improvements.
• Work with delivery head & SME to develop, implement Quality Management Plan, provide
inputs to Quality Agreements, Training Plans, and monitor Quality SLAs for all designated projects.
• Assume accountability of supporting the client during regulatory inspections and ensuring quality and timely completion of inspection requests.
• Ensure implementation of Quality Management Plan and/or the Quality Agreement for assigned projects.
• Support Computer System Validation related activities as required.
• Perform a critical role to ensure organization wide inspection readiness at all times.
• Develop general or client-specific PV SOPs and WIs.
• Assess client conventions and provide inputs on their relevance to regulatory requirements.
• Assist delivery teams to identify training needs based on quality review findings.
• Identify process improvements and support delivery teams in the implementation.
• Support practice head in developing process framework, new offerings, and customized solutions for clients.
• Assist practice head in ensuring that training material & training plans are reviewed and updated on an ongoing basis, and in conducting training sessions.
• Support business development at practice level by contributing to RFP responses, proposals, and client presentations.
• All other duties as needed or assigned.
Qualifications(Minimum Required):
• Bachelors/Masters/PhD degree in Medicine or Alternative medicine, Medical Science,
Pharmaceutical science, Nursing, Life Sciences, or related area.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Experience (Minimum Required):
• 10 years of experience in the pharmaceutical industry, biotechnology, or CRO industry
primarily in Pharmacovigilance / Safety writing with experience in Quality, leading quality, and process improvements across several Safety projects.
• Knowledge of regulatory requirements viz. GPV and applicable EU and FDA guidelines.
• In-depth understanding of single case processing, assessment, and safety writing.
• Understanding of Lean and Six sigma methodologies.
• Technical proficiency with Microsoft Office suite of applications.
• Understanding ofsystem validations.
Preferred Qualifications Include:
• Experience in assessing quality of a case/safety report from a medical, scientific and documentation perspective; experience in trending, identification of gaps & training needs is preferred.
Learn more about our EEO & Accommodations request here.
Bringing life-changing benefits to patients faster
Fortrea (Nasdaq: FTRE) is a leading global clinical research organization (CRO) dedicated to providing innovative clinical development solutions to the life sciences industry. With over 30 years of clinical research experience, Fortrea has evolved from Covance and Labcorp into a pureplay CRO built for biotech, biopharma, medical device and diagnostic innovators. Fortrea collaborates with both emerging and established companies to deliver agile, fit-for-purpose full service (FSO), functional service (FSP) and hybrid solutions. Fortrea provides comprehensive Phase I-IV clinical trial management, clinical pharmacology, and consulting services, backed by deep experience in more than 20 therapeutic areas. Operating in approximately 100 countries, our diverse and talented team brings scientific rigor, operational excellence, and a strong investigator site network to every trial. By combining the best of our legacy experience with forward-thinking innovation, Fortrea brings predictability to clinical trial execution and helps transform aspirations into outcomes. Together, exceptional is possible. Learn more at Fortrea.com
Offices: Research Triangle Park, NC, US
Bringing life-changing benefits to patients faster
Fortrea (Nasdaq: FTRE) is a leading global clinical research organization (CRO) dedicated to providing innovative clinical development solutions to the life sciences industry. With over 30 years of clinical research experience, Fortrea has evolved from Covance and Labcorp into a pureplay CRO built for biotech, biopharma, medical device and diagnostic innovators. Fortrea collaborates with both emerging and established companies to deliver agile, fit-for-purpose full service (FSO), functional service (FSP) and hybrid solutions. Fortrea provides comprehensive Phase I-IV clinical trial management, clinical pharmacology, and consulting services, backed by deep experience in more than 20 therapeutic areas. Operating in approximately 100 countries, our diverse and talented team brings scientific rigor, operational excellence, and a strong investigator site network to every trial. By combining the best of our legacy experience with forward-thinking innovation, Fortrea brings predictability to clinical trial execution and helps transform aspirations into outcomes. Together, exceptional is possible. Learn more at Fortrea.com
Offices: Research Triangle Park, NC, US
