Clinical Study Disclosure Manager
CK Group are recruiting for a Clinical Study Disclosure Manager to join a Swiss high-potential biopharmaceutical company, specialized in the discovery, development and commercialization of innovative small molecules, with the aim of transforming thehorizon of therapeutic options.
The position will be for a 12-month contract, located near at the clients office near Basel, the rate for this role will be 69.49 - 87.49 CHF per hour.
The Clinical Study Disclosure Manger will be responsiblefor 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 include:
- 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 and 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.
- Preferably, a higher degree in medical or life sciences. Other scientific degree may be acceptable if associated with appropriate pharmaceutical industry experience.
- Minimum of 5 years’ experience in the pharmaceutical industry or related to the conduct of clinical trials.
- Solid understanding of theclinical 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.
Please quote job reference 56617 in all correspondence. Applicants need full rights to work in Switzerland