Country Study Manager FTC 12 months
CK Group are recruiting for a Country Study Manager to join a company in the pharmaceutical industry at their site based in Hertfordshire. This is a 12-month fixed term contract, with access to client bonus/benefit scheme.
The Company: Our client is a world leading innovative pharmaceutical company that is committed to improving the lives of patients.
Country Study Manager Role: The main purpose of the role will be to provide leadership and regional/local strategic planning and operation delivery to assigned clinical studies through all phases of study management (preparation, study start-up, conduct, close out), in line with quality standards.
- Full accountability and oversight for all assigned studies atcountry level in line with the overall project plan, manage and maintain accurate country/study level plans.
- Lead local study teams, representing country clinical operations at the Global SMT, and provide global teams with feedback from an affiliate perspective.
- Plan and execute country study goals and commitments.
- Provide study oversight, leadership and support to contract research organisation staff to ensure overall delivery at country and site level.
- Oversee study feasibility, site monitoring performance, preparation of risk based monitoring plans and ensures eTMF completeness and oversight of all relevant compliance activities.
- Collaborate in local quality/compliance reviews, internal audits, and regulatory inspections,ensuring inspection readiness at all times and completion of CAPA for allocated studies.
- Develop and maintain optimal site relationships with key investigator sites, alliance partners and/or collaborative group for current and future studies.
- University degree in a medical/science-related field.
- Proven experience in project management including implementation of risk management plans and management of complex study budgets and resourcing plans.
- Demonstrated ability to prioritise and manage multiple tasks.
- Self-motivated and achievement driven.
- Excellent knowledge of ICH GCP.
- Strong computer skills - experience using various computer applications including spreadsheets, email, word-processing software.
Apply: For more information or to apply for this Country Study Manager position, please contact Russell Oakley on 01246 457709 or email firstname.lastname@example.org, quoting job ref 50320.
It is essential that applicants hold entitlement to work inthe UK.