Clinical Study Disclosure Manager in Basel-Land
Clinical Study Disclosure Manager - Basel-Land
Jocelyn Blackham is recruiting for a Clinical Study Disclosure Manager to join a rapidly growing drug discovery company at their site based in Basel-Land on a contract basis for 12 months, with the possibility of extension.
The main purpose of the role will be to:
- Lead, execute and manage current and future clinical trial disclosure and transparency activities.
- 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 company 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.
Further responsibilities will include:
- 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.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Preferably, a higher degree in medical or life sciences. Other scientific degree may be acceptable if associated with appropriate pharmaceutical industry experience.- Previous experience in the pharmaceutical industry or related to the conduct of clinical trials.
- 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.
This is an excellent opportunity to join a rapidly expanding pharmaceutical company.
For more information or to apply for this position, please contact Jocelyn Blackham on 0041 (0) 782 516 595 or email jblackham@ckqls.ch. Please could you send any correspondence in English. Please quote reference 45353 in all correspondence.