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Senior Clinical Scientist (m/w/d) (EN)
[12977]
Clinical Affairs
Job title: Senior Clinical Scientist Consultant (m/w/d) Industry: Pharma Skills: Clinical Affairs Start of project: 01.06.2023 (Potential) Duration of the project : 6 Months + Project volume: TBD Location: Lausanne Tasks: ·Drive development of protocols/protocol amendments for clinical studies ·Prepare and/or provide input to clinical study related and other regulatory documents (e.g. CSRs, IBs, PIS/ICFs, SAPs, Data Management Plans, Safety Management Plan, Medical Monitoring Plan, SRC Charter, IND, briefing books) ·Prepare and/or provide input to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses) Qualifications: ·Master's in Life Sciences, Pharmacist or PhD in Life Sciences (preferred) ·At least 7-10 years of relevant experience in clinical development within the pharmaceutical industry, including development of CDPs and protocols ·Experience in conducting Clinical Studies in Oncology
Skills: Clinical Affairs
- Drive development of protocols/protocol amendments for clinical studies
- Prepare and/or provide input to clinical study related and other regulatory documents (e.g. CSRs, IBs, PIS/ICFs, SAPs, Data Management Plans, Safety Management Plan, Medical Monitoring Plan, SRC Charter, IND, briefing books)
- Prepare and/or provide input to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses)
- Master's in Life Sciences, Pharmacist or PhD in Life Sciences (preferred)
- At least 7-10 years of relevant experience in clinical development within the pharmaceutical industry, including development of CDPs and protocols
- Experience in conducting Clinical Studies in Oncology
