Assignment Details
- Workload: ~20 hours/week to start (likely to increase)
- Engagement: Consulting/contract
- Start: ASAP
- Location: Belgium (hybrid; on-site ideally once per week)
Clinical Trial Manager (Consultant) – Phase 3 Diagnostic Development | Belgium (Hybrid)
We are supporting a diagnostics-focused biotech seeking an experienced Clinical Trial Manager (CTM) to guide a peptide-based diagnostic product through late-stage development. This is a part-time consulting role with scope to increase as the trials advance.
The Role
- Lead identification and evaluation of clinical trial sites across Europe and/or the US
- Develop and implement patient recruitment strategies and realistic study timelines
- Oversee trial documentation, TMF accuracy, regulatory files, and site communication
- Provide strategic guidance on Phase 3 planning (country selection, site feasibility, regulatory pathways)
- Advise from a CDMO/technical operations perspective to ensure alignment with manufacturing and regulatory needs
- Support vendor oversight, site readiness, and operational risk management
What You Bring
- Strong background in Clinical Trial Management within biotech, pharma, diagnostics, or imaging
- Demonstrated experience moving programs from Phase 2 to Phase 3
- Experience with diagnostic agents, peptides, radiopharma, or complex modalities is highly advantageous
- Solid understanding of EU and US regulatory frameworks, start-up processes, and site operations
- Ability to work independently, provide senior-level guidance, and operate in a lean environment
Solliciteren