Clinical trial activation is one of the most critical drivers of bringing new therapies to patients — and in this role, you will be at the heart of it. As a Study Start‑Up Lead within our Research and Development organization, you will own and drive the end‑to‑end study start‑up process across a diverse and complex clinical portfolio, from country and site identification through to site activation. You will develop and execute the Study Start‑Up Operational Plan, set clear delivery expectations, and ensure that timelines, metrics, and reporting are consistently met across all assigned studies.
Working closely with Clinical Trial Leads, Functional Leads, and local team members, you will proactively identify and resolve start‑up challenges, coordinate feasibility efforts, and partner with the Operational Design Center on country and site selection. You will lead the ethics and regulatory submission strategy — including preparation of the CTIS Part 2 packages — and oversee the Essential Document Package process to ensure full alignment at both study and local level for site activation. You will also work closely with the site budget development and contract negotiations team, to deliver best‑in‑class site activation timelines.
Who You Are
- Substantial experience in clinical research, including significant hands‑on expertise in global study start‑up leadership within a pharmaceutical, biotechnology, or contract research organization environment
- In‑depth knowledge of international regulatory requirements and guidelines, including ICH Good Clinical Practice and applicable European Union directives
- Proven expertise in central and local ethics committee submission processes across multiple countries, with regulatory affairs knowledge considered a strong advantage
- Demonstrated ability to develop country‑ and site‑specific start‑up strategies, manage risk proactively, and apply contingency planning in complex, multi‑stakeholder environments
- Experience coordinating site budget development and contract negotiations with internal and external parties
- Strong communication skills with the ability to convey complex information clearly to diverse audiences, including cross‑functional teams and external partners
- Highly organized, with the ability to manage competing priorities independently and collaborate effectively within a cross‑functional, international team structure
Location
Feltham, United Kingdom | Hybrid — minimum 3 days per week on site.This role can also be based in Germany, Poland or Greece — minimum 3 days per week on site.
What we offer
We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress.
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