Clinical Study Disclosure Manager

Inactive

Reference Number: 896312-W
Type of placement: Contract, 12 months
Location: CH, NW

Introduction:

Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking a Clinical Study Disclosure Manager for a 12  months contract based in Basel area.

The ideal candidate should have 5 years of previous experience in the pharmaceutical industry or related to the conduct of clinical trials. The Clinical Study Disclosure (CSD) Manger will be responsible for leading, executing and managing current and future clinical trial disclosure and transparency activities. This role will report to the Head of Medical Writing & Clinical Study Disclosure and will serve as a subject matter expert for matters related to clinical trial transparency.

Main Responsibilities:

  • Drive the processes for clinical study protocol registration and summary results posting on public clinical trial registries.
  • Ensure accuracy, consistency, quality, and compliance of publicly disclosed clinical trial information, in accordance with applicable global clinical transparency regulations, policy and processes.
  • Work with study and/or project teams (e.g., Therapeutic Area, Clinical operations, Biostatistics, Regulatory Affairs, Life Cycle Management, Patent and Legal) to plan and execute study disclosure activities.
  • Serve as a subject matter expert, advise on evolving global clinical trial disclosure and transparency laws, regulations, and requirements, and provide guidance on best practices.
  • Provide leadership for transparency initiatives such as lay language results summaries or clinical data sharing.
  • Proactively identify opportunities to improve systems and processes and lead process improvement initiatives for disclosure/transparency.

Qualifications and Experience:

  • Preferably, a higher degree in medical or life sciences. Other scientific degree may be acceptable if associated with appropriate pharmaceutical industry experience.
  • Solid understanding of the clinical drug development life cycle, including clinical trial design, operations and results analysis.
  • Demonstrated experience of clinical trial disclosure and transparency processes and systems, including a detailed understanding of the variable global requirements and the evolving landscape.
  • Sound ability to understand, interpret, critically analyze, and summarize complex scientific and medical data.
  • Detailed-oriented with a high degree of organizational skills.
  • Excellent written and oral communication skills.
  • Ability to work independently and as part of a team.
  • Relevant working/residency permit or Swiss/EU-Citizenship required.