Clinical Project Scientist (m/f)

REFERENZNUMMER:

374194/11

IHRE AUFGABEN:

-Develop a comprehensive understanding of the science and medicine relating to a project
-Perform literature reviews, and write position papers when required
-Responsible, with the CPP, for delivering documents as Clinical Project Development Plan (CDP), Program Development Challenge Document (PDCD), Clinical Overview and clinical summaries, Communication I Publication Plan (PP), HAs’ annual reports, Risk Management Plan (RMP), Pediatric Investigational Plan (PIP) etc.
-Project-related medical monitoring, including safety monitoring, activities
-Contact and meeting with experts and Key Opinion Leaders

IHRE QUALIFIKATIONEN:

-PhD, PharmD, DVM, MSc or equivalent degree in Biological Sciences
-Profound experience in clinical research or clinical development in a CRC, or 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
-Fluency in English

WEITERE QUALIFIKATIONEN:

Clinical project manager