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Consultant – CRA Manager
Ividata Life Sciences. Lead, train, and provide day-to-day support to a team of in-house and outsourced Clinical Research Associates (CRAs) .
About the role
Key responsibilities & impact- Lead, train, and provide day-to-day support to a team of in-house and outsourced Clinical Research Associates (CRAs)
- Conduct performance reviews and monitor team members’ professional development
- Oversee the management and follow-up of investigator sites
- Review and approve site selection, initiation, monitoring, and close-out visit reports
- Ensure recruitment targets are met
- Ensure compliance with study protocols, ICH Good Clinical Practice (ICH-GCP), and applicable regulations
- Participate in study budget monitoring
- Manage key performance indicators (KPIs)
- Manage relationships with service providers, including CROs and laboratories
- Anticipate risks and manage major protocol deviations
- Implement corrective and preventive action (CAPA) plans
- Collaborate with pharmaceutical and biotechnology clients on high-value projects
Requirements
What you’ll need- Advanced scientific degree (Master’s degree, PhD, or Doctor of Pharmacy)
- Specialized training in clinical research (FARC, Sup Santé, or equivalent)
- At least 5 years of experience in clinical research, either with a sponsor or CRO
- Proven experience in oncology
- Successful initial experience managing a CRA team or working as a Lead CRA / Clinical Trial Manager
- Strong understanding of the specific requirements of Phase III clinical trials
- Fluency in written and spoken English is essential
- Ability to apply study protocols, ICH Good Clinical Practice (ICH-GCP), and ANSM, CNIL, and RIPH regulations
- Proficiency in investigator site management and review of visit reports
- Skills in budget monitoring, KPI management, and vendor management, including CROs and laboratories
- Skills in managing protocol deviations and implementing corrective and preventive action (CAPA) plans
Benefits
Comp & perks- Possibility of partial remote work
- Stimulating and collaborative work environment
- High-impact assignments
- Opportunities for career development alongside experts in healthcare innovation
- Opportunities to work with pharmaceutical companies, biotech firms, medical device companies, animal health, cosmetics, and nutrition organizations