Reg and Study Start up
FRANCE
il y a 12 jours
Location: remote (Must be based in France)
Are you passionate about enabling high‑quality clinical research and ensuring trial sites are ready to deliver? We’re looking for a detail‑oriented and proactive Site Activation Specialist to join our global team.
In this role, you’ll support country‑level Site Activation (SA) activities and act as a key liaison across investigative sites, project teams, and regulatory stakeholders. If you thrive in a fast‑paced, regulated environment and enjoy working cross‑functionally, this could be the perfect next step.
What You’ll Do
- Serve as the Single Point of Contact (SPOC) for assigned studies across investigative sites and internal teams
- Lead and coordinate start‑up and site activation activities in line with SOPs, regulatory requirements, and project timelines
- Prepare, collect, and review site regulatory documents for completeness and accuracy
- Track and follow up on ethics submissions, regulatory approvals, Informed Consent Forms (ICFs), and Investigator Pack (IP) release documents
- Maintain and update internal tracking systems, databases, and project toolsSupport project planning, timelines, and contingency measures
- Conduct quality control checks on site documentation
- Provide local regulatory expertise to project teams and Site Activation Managers
- Communicate progress and milestones with internal and external stakeholders
- Occasionally engage directly with sponsors on specific initiatives
What You Bring
- Bachelor’s degree in Life Sciences or a related field
- 3+ years of clinical research experience , including at least 1 year in a leadership or coordination role
- Strong understanding of GCP/ICH guidelines and local regulatory requirements
- Experience working with clinical systems, SOPs, and standardized processes
- Excellent communication, negotiation, and interpersonal skills
- Ability to manage multiple projects , prioritize effectively, and work independently
- Strong attention to detail and a commitment to high‑quality deliverables
- A collaborative mindset and the ability to build effective working relationships
Why Join Us?
- Work within a supportive, knowledgeable, and collaborative global team
- Contribute directly to advancing clinical research and improving patient outcomes
- Opportunities for growth and development within a leading organization
- Competitive compensation and benefits package
Entreprise
Actalent
Plateforme de publication
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