Country Study Manager

  • Salary: Between £380-£425 per day
  • REF Number: 00049883
  • Consultant: Russell Oakley
  • Contact: 01246 457709
  • Date Published: 26.02.2021
  • Sector:
  • Location: Welwyn, London
  • Discipline:

CK Clinical are recruiting for a Country Study Manager to join a company in the pharmaceutical industry on a 12 month contract at their site based in Hertfordshire.

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 phasesof 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 completionof 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@ckclinical.co.uk, quoting job ref 48535.

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

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