Clinical Project Scientist

Clinical Project Scientist - 12 month contract - On site in Basel, Switzerland

We are currently working with a world leading Pharma that is looking for a Clinical Project Scientist on a 12 month contract basis, to design and deliver clinical trials across multiple indications in their headquarters in Basel.

Responsibilities:

• Design and ensure delivery of multiple clinical trials, working closely with the program physician.
• Provide insight and input into the design of trial documents, protocols, relevant materials for health authority review and regular summaries/overviews pf the trials.
• Represent the trials and programs they are responsible for at internal stakeholders.
• Provide cross functional leadership and teamwork with multiple departments, ensuring timely delivery of trials goals within budget.

Requirements:

• 10+ years of experience within a Pharmaceutical company or CRO, working across phase II and III trials from planning to close out.
• PhD, PharmD, MSc or equivalent university degree in life sciences
• Extensive experience in writing study protocols, ICFs and general trial related documents.
• Extensive experience in data review and medical monitoring of clinical trials.
• Previous experience in scientific contributions to documents such as Investigator's Brochures (IBs), briefing books for health authority meetings, Pediatric Investigational Plans (PIPs), clinical overviews, and summaries.
• Strong understanding of Medical Affairs requirements and prior collaboration experience.
• Prior exposure to preclinical development activities is highly desirable.
• Comprehensive understanding of regulatory requirements and International Council for Harmonisation (ICH) guidelines.
• High level of spoken and written English