Senior Clinical Trial Scientist
Senior Clinical Trial Scientist
Job Title : Senior Clinical Trial Scientist.
Work Location : Allschwil.
Country : Switzerland.
Schedule : Fulltime (100%).
Desired start date : Beginning September.
Duration : 12 months.
Contractor Rate : CHF 65.25 CHF 73.72 depending on experience.
Job Responsibilities :
The Senior Clinical Trial Scientist is representing clinical science as core member of the Clinical Trial Team and contributes to the following trial-level activities :
- Collaborates closely with the Clinical Trial Physician, Clinical Project Physician and / or Clinical Project Scientist on relevant trial-related activities.
- Develops 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.
- Main deliverables include the clinical trial protocol and related documents such as the ICF, trial committee charters, trial guidelines / instructions, PD code list, participant narratives, and the CSR.
- Provides input into and reviews cross-functional trial documents such as the SAP, external service provider requirements and specifications, monitoring guidelines, data review manual.
- Performs data review and medical monitoring during the conduct of the trial.
- Coordinates / manages the study committees.
- Provides scientific input into responses for IRBs / ECs, HAs, sites and monitors.
- Participates in discussions with external experts.
- Trains the relevant functions and roles on the scientific aspects of the trial.
- Contributes to cross-functional and clinical development initiatives and processes as needed.
Candidate Requirements :
- PhD, Pharm D, MSc or equivalent university degree in life or health sciences.
- At least 5 years of working experience preferably in clinical development in a contract research organization (CRO) or pharmaceutical company.
Monitoring experience is an advantage.
- Experience in the planning, set-up, conduct, closing, and reporting of phase II and III clinical studies from a scientific and operational perspective.
- Previous authoring / co-authoring of clinical trial protocols, ICFs, scientific trial-related documents (e.g., trial committee charters) is an advantage.
- Previous experience in the Therapeutic area of Cardiovascular, Renal and / or Central Nervous System Diseases is an advantage.
- 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.
- Fluent in written and spoken English.
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