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Clinical Project Scientist
Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, is looking a Clinical Project Scientist for permanent role based in Basel, Switzerland.
- Provide scientific input into relevant documents such as the Clinical Development Plans, Communication Plans, Investigators Brochures, clinical overviews and summaries, etc.;
- Collaborate closely on relevant projects activities with the Clinical Project Physician and jointly represent the project during internal and external meetings;
- Provide scientific input to medical monitoring activities on project level;
- Gain an expert understanding of the scientific and medical elements of clinical trials, including understanding the competitive landscape, contributes as needed to trial-level activities and provide mentorship and training to junior colleagues;
- Participate in meetings with health authorities as well as in life cycle activities and life cycle meetings.
Qualifications and Experience:
- Swiss working/residency permit and/or Swiss/EU-Citizenship required;
- PhD, Pharm D, MSc or equivalent university degree in Neurology, Neuroscience, or disciplines related to Neuroscience, CNS or Insomnia;
- At least 3 years of working experience as a Clinical Scientist, working on Phase II and III clinical studies within a CRO, biotech and/or pharma company;
- Experience in independently writing clinical study protocols, ICFs, scientific trial-related documents e.g., study committee charters;
- Solid experience in planning, set-up, conduct, closing, and reporting of phase II and III clinical studies from a scientific perspective;
- Previous scientific contribution to cross-functional trial documents (e.g., SAP) guidelines, CRFs;
- Solid experience with data review/medical monitoring;
- Good understanding of the drug development process, trial-related regulatory requirements/ICH GCP guidelines.
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