Clinical Outsourcing & Risk Manager

Inactive

Reference Number: 895822-W
Type of placement: Contract, Permanent
Location: Switzerland, North West

Introduction:

Our client is a Swiss biopharmaceutical company looking for a Clinical Outsourcing & Risk Manager for a permanent role based in the Basel area, Switzerland.

The ideal candidate should have previous experience in managing clinical outsourcing and External Service Provider in the pharmaceutical industry or CRO. 

Main Responsibilities:

  • Identify and evaluate potential ESPs
  • Partner with Clinical Trial Leaders and other study management team member(s) as needed to assess outsourcing needs and requirements. Assist in the definition of work specifications and build Request For Information (RFI) and Request For Proposal (RFP)
  • Facilitate ESP selection and ensure documentation of rationale for selected vendor (SWOT analysis) using a risk based vendors selection process (e.g. structured questionnaires based on quantitative, qualitative and performance criteria)
  • Support the development, negotiation and timely execution of ESP contracts ensuring quality as per defined specifications and oversee legal & financial review
  • Facilitate implementation of quality agreement between Sponsor and ESP
  • Negotiate contract terms, including pricing, deliverables, milestones and payment schedule, ensuring that the agreements with the ESPs are in line with the budget goals
  • Support the Clinical Trial Leader(s)/Manager(s) to define key risk indicators (KRIs) and Key Performance Indicators (KPIs) measuring performance as well as risks associated with quality standards and contract’s deliverables in all operational areas (systems, processes and infrastructure)
  • Monitor ESP performance in adherence to contractual terms and according to defined Key Performance Indicators and Key Risks Indicators
  • Support/facilitate the development of a risk-based approach to monitoring clinical trials with a combination of on-site and centralized monitoring activities as appropriate. Ensure rationale for type of study monitoring chosen is documented on a monitoring plan
  • Determine with CTL/CTM and Compliance Officer vendor audits needed

Qualifications and Experience:

  • More than 5 years of pharma/biotech experience in clinical or observational studies, with demonstrated management of clinical outsourcing, External Service Provider (ESP) and/or Functional Service Provider (FSP)
  • University or equivalent education/degree
  • Advanced understanding of the clinical development process and understanding of the management of clinical trials
  • Familiarity with Outsourcing industry, i.e. CRO, Central Laboratories/Reference Laboratories, ECG, IVRS, etc
  • Excellent planning and organizing skills, able to manage multiple programs and processes simultaneously
  • Excellent interpersonal, negotiation and influencing kills
  • Good command of written and spoken English
  • Relevant working/residency permit or Swiss/EU-Citizenship required

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