Country Study Manager FTC 12 months

1 day left

CK Group
Welwyn Garden City
£53000 - £58000 per annum
07 Apr 2021
14 Apr 2021
Russell Oakley
Contract Type
Full Time
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 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.

For more information or to apply for this Country Study Manager position, please contact Russell Oakley on 01246 457709 or email, quoting job ref 50320.

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

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