Senior Clinical Trial Scientist
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 Senior Clinical Trial Scientist for a permanent position based in Basel area.
The ideal candidate should have 5 years of previous experience in clinical research in a clinical research organization (CRO) or Pharmaceutical Company.
- Collaborates closely with the Clinical Project Physician and 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, study committee charters, study guidelines/instructions, PD code list, subject narratives, and the CSR;
- Provides input into and reviews cross-functional trial documents such as the SAP, ESP 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 and Has;
- 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.
Qualifications and Experience:
- 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;
- 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;
- Previous experience in the Therapeutic area of Rare 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;
- Relevant working/residency permit or Swiss/EU-Citizenship required.