Senior Clinical Project Scientist

Reference Number: 895648-W
Type of placement: , Contract 36 months

Introduction:

Our client is looking for a Senior Clinical Project Scientist

Main Responsibilities:

 

Tasks and activities at the project level:

  • Develop a comprehensive understanding of the science and medicine relating to a project
  • Perform literature reviews, and write position papers when required
  • Is responsible, with the Physician, for delivering the following documents:
  • Clinical Project Development Plan (CDP)
  • Program Development Challenge Document (PDCD)
  • Clinical Overview and clinical summaries
  • Project specific definition document
  • Project specific coding guidelines-Communication I Publication Plan (PP)
  • Investigator Brochure (IB)
  • Health Authorities’ (HA) Briefing Books (BB)
  • HAs’ annual reports
  • Risk Management Plan (RMP)
  • Pediatric Investigational Plan (PIP)
  • Is responsible, with the Physician, for the following activities:
  • Contact and meeting with experts and Key Opinion Leaders
  • Implementation of the clinical part of the PP
  • Answer to project-related HA questions
  • Is consultation for:
  • Clinical Project team coordination
  • Project-related medical monitoring, including safety monitoring, activities
  • Meeting with Health Authorities
  • Early Access program

Qualifications and Experience:

 

  • PhD, PharmD, DVM, MSc or equivalent degree in Biological Sciences
  • At least 5 years experience in clinical research or clinical development in a pharmaceutical company
  • Clinical research experience in the indication relevant to the Clinical Project is preferred
  • Sound knowledge of drug development and clinical trial process based on previous deliverables
  • Sound knowledge of regulatory requirements/ICH guidelines
  • Good organizational skills, able to work as part of a team and independently
  • Excellent communication skills
  • Detail oriented
  • Fluent in English
  • Relevant working/residency permit or Swiss/EU- Citizenship required

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