Consultant - ARC Manager (M/F)
About the company
Why join us? At IVIDATA Life Sciences, we place expertise at the heart of our actions. Alongside the major players in the sector (pharmaceutical laboratories, biotech, medical devices, animal health, cosmetics, nutrition), our consultants intervene across the entire product life cycle: from preclinical research to industrialization.
Our 160 consultants deploy their skills in five key areas: Biometry, Clinical Operations, Regulatory Affairs, Pharmacovigilance, Quality Assurance.
Your tasks
Within the IVIDATA Life Sciences teams and in collaboration with our clients from the pharmaceutical and biotechnology sectors, you will work on high-value-added projects as an ARC Manager to:
Management & Leadership: Supervise, train, and support an ARC team (internal/external) on a daily basis; conduct performance evaluations and monitor their development.
Study Oversight: Supervise the monitoring of investigator sites, validate visit reports (selection, initiation, monitoring, close-out), and ensure recruitment objectives are met.
Quality Assurance & Compliance: Ensure strict application of protocols, Good Clinical Practices (GCP-ICH), and current regulations (ANSM, CNIL, RIPH).
Project & Budget Management: Participate in monitoring study budgets, drive key performance indicators (KPIs), and manage relationships with service providers (CROs, laboratories).
Risk Management: Anticipate deviations, manage major protocol deviations, and implement corrective action plans (CAPA).
Requirements
Do you have a solid profile in clinical research, confirmed expertise in managing ARC teams, and wish to join a dynamic structure at the heart of innovation in Life Sciences? Join us!
Your profile Higher scientific degree (Bac+5 / Master 2, Doctorate, Pharmacist) supplemented by specialized training in clinical research (FARC, Sup Santé, etc.)
At least 5 years of experience in clinical research (Sponsor or CRO), including significant experience in oncology.
A first successful experience in ARC team management or as a Lead ARC / Clinical Trial Manager.
Solid mastery of the specific constraints of Phase III trials.
Fluent English is essential (written and oral, international environment).
What we offer
By joining our team, you will evolve in a stimulating, collaborative, and constantly evolving environment, where your ideas and expertise will have a real impact.
Other
Position based in Paris with the possibility of partial teleworking.