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Study Site Management Specialist
vor 5 Stunden
Study Site Management Specialist ( 1-2 Years Experince) – FSP Model (Advanced Clinical) Oncology-focused Pharmaceutical Company We’re looking for a motivated, detail-oriented Site Start-Up Specialist to join our FSP team and support global clinical studies through Advanced Clinical. This is a great opportunity for someone earlier in their career who is keen to deepen their experience in site start-up, contracts, and regulatory submissions within a supportive and collaborative environment. Under the guidance of SSU and Study Support leadership, you’ll support end-to-end site start-up activities, from feasibility through to site activation. You’ll act as a key point of contact for study teams, working closely with internal and external stakeholders to ensure a smooth, efficient site setup. Key responsibilities include: Supporting and coordinating end-to-end site start-up activities Acting as the primary point of contact for study teams on start-up-related tasks Supporting feasibility assessments, site identification, and site qualification activities Managing and tracking study start-up activities using internal tools and reports Supporting site contract and budget negotiations Collecting, reviewing, and tracking essential regulatory documentation Assisting with Ethics Committee and Regulatory Authority submissions Supporting country- and site-level regulatory and activation activities as required What we’re looking for: Bachelor’s degree in Science or a related field Strong written and spoken English Solid understanding of clinical research principles and processes Around 5 years’ experience in site start-up and contract management within a CRO or pharmaceutical environment Good working knowledge of ICH-GCP, regulatory requirements, and clinical trial processes Strong organisational, communication, and interpersonal skills Confidence using MS Office (Word, Excel, PowerPoint, Outlook) This role suits someone who enjoys working collaboratively, has strong attention to detail, and is keen to continue building their career in clinical research within a global setting.
