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.

Responsibilities:

• Full accountability and oversight for all assigned studies at country 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.

Your Background:

• 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 roakley@ckgroup.co.uk, quoting job ref 50320.

It is essential that applicants hold entitlement to work in the UK.