Jocelyn Blackham is recruiting for a Clinical Trial Scientist to join a growing pharmaceutical company at their site based in Allschwil (Basel-Land) on a contract basis for 12 months.
The main purpose of the role will be to:
- Collaborate closely with the Clinical Project Physician and Clinical Project Scientist on relevant trial-related activities.
- Develop a sound understanding of the science and medicine related to an indication and trial and performs literature searches as needed to keep knowledge up to date.
- Complete the clinical trial protocol and related documents such as the ICF, study committee charters, study guidelines/instructions, PD code list, subject narratives, and the CSR.
- Provide input into and reviews cross-functional trial documents such as the SAP, ESP requirements and specifications, monitoring guidelines, data review manual.
Further responsibilities will include:
- Performing data review and medical monitoring during the conduct of the trial.
- Coordinate/manage the study committees.
- Provide scientific input into responses for IRBs/ECs and Has.
- Participate in discussions with external experts.
- Trains the relevant functions and roles on the scientific aspects of the trial.
- Contribute to cross-functional and clinical development initiatives and processes as needed.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- PhD, Pharm D, MSc or equivalent university degree in life or health sciences.
- Previous working experience preferably in clinical development in a contract research organization (CRO) or pharmaceutical company.
- Previous experience in either the planning, set-up, conduct, closing, and reporting of phase II and III clinical studies from a scientific perspective is an asset.
- Good knowledge of drug development and clinical trial process.
- Good knowledge of regulatory requirements/ICH guidelines.
- Demonstrated ability to work independently in a fast-paced environment, to prioritize multiple competing tasks, to proactively address issues and demands.
This is an excellent opportunity to join a rapidly expanding pharmaceutical company.
Please could you send any correspondence in English. Please quote reference 47248 in all correspondence