Contract Clinical Program Director

Up to £750 per day
  1. Contract
  2. Program Manager / Director
  3. United Kingdom
London, England
Posting date: 10 Jun 2021
38143

An exciting opportunity has arisen for a contract Clinical Program Director to lead a Global Project Team. You will work with the development team to design operational inputs but also develop programme strategy.

Job Responsibilities

  • Plans, directs and delivers the operational components of assigned clinical programs from design concept to final CSR, through to study closed and archived within agreed budget, time, quality and aligned KPIs
  • Leads and delivers differentiated and robust operational options for review at Investment Decision Governance interactions
  • Leads operational discussions with external entities including regulatory agencies, preferred partners/suppliers and external collaborators
  • Develops and maintains effective program level risk management/mitigation plans to ensure timely delivery to quality and budget
  • Accountable for planning and leading issue escalation and resolution
  • Accountable for the acquisition of clinical trial data from internal and external sources
  • Input to the study delivery related activities associated with regulatory inspections/audits in liaison with Clinical Quality Assurance
  • Accountable for the quality of study delivery planning information into relevant planning systems
  • Accountable for coordination of selection of external providers for programme/study specific tasks
  • Provision to procurement of clear specifications for program/study specific outsourcing
  • Review and operational approval of program/study specific contracts or work orders
  • Operational management and oversight of external providers at program/study level
  • Engagement with preclinical and translational science as well as statistics and regulatory in order to design and deliver robust clinical development plans.

Skills and Requirements

  • Minimum BA/BSc
  • At least three years' relevant experience in clinical development including team leadership.
  • Experience or capability to manage in-house and/or outsourced regional or global Phase 1, 2 or 3 studies from study start-up to study report completion.
  • A SrCPM must have substantial experience in study management in different indications and proven ability to manage complex multinational studies or multiple simultaneous studies from start to end.

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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