FSP Site Activation & Contracts Specialist – Middle East
Thermo Fisher Scientific
Darbo aprašymas
About the role
The FSP Site Activation & Contracts Specialist will manage the end‑to‑end site activation process for clinical study sites across the Middle East. The role combines study start‑up activities with contract and budget negotiations to ensure timely site readiness. You will act as the primary contact for assigned sites and collaborate with internal and external stakeholders to remove activation barriers.
Key responsibilities
- Manage sites from selection/award through activation readiness, coordinating collection and review of essential start‑up documents.
- Prepare, submit and follow up on Ethics Committee/IRB and regulatory submissions in line with country‑specific requirements.
- Track activation milestones, identify potential delays and proactively engage sites and stakeholders to meet timelines.
- Ensure all start‑up documentation is complete, accurate and uploaded to the appropriate systems and eTMF.
- Draft, execute and process clinical trial agreements, investigator agreements and related contractual documents.
- Negotiate investigator grant budgets and contractual terms within approved parameters and coordinate escalations when needed.
- Monitor contractual progress, communicate status, risks and escalations to study and contract management teams.
- Support eTMF quality control and resolve related issues as required.
Required profile
- Experience managing site activation and contract processes for clinical trials in the Middle East.
- Strong knowledge of regional and national regulatory, Ethics Committee and IRB requirements.
- Ability to track milestones, identify delays and drive timely resolution.
- Excellent communication skills to serve as the key point of contact for sites and internal teams.
- Detail‑oriented with ability to ensure accurate documentation and filing.
Required skills
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