Clinical Trial Expert
Vor 2 Tagen
Overview:
We are seeking a highly skilled Clinical Trial Expert to join our team at Actalent. In this role, you will collaborate closely with the Clinical Project Scientist on trial-related activities, developing a deep understanding of the science and medicine related to the trial.
Job Responsibilities:
- Collaborate with the Clinical Project Scientist to ensure successful trial execution.
- Develop a sound understanding of the science and medicine related to an indication and trial.
- Main deliverables include the clinical trial protocol and related documents.
- Provide input into cross-functional trial documents.
- Perform data review and medical monitoring during the conduct of the trial.
- Coordinate/manage the study committees.
- Provide scientific input into responses for IRBs/ECs, HAs, sites and monitors.
Required Skills and Qualifications:
- PhD, Pharm D, MSc or equivalent university degree in life or health sciences.
- At least 4 years of working experience preferably in clinical development in a contract research organization (CRO) or pharmaceutical company.
- Experience in planning, set-up, conduct, closing, and reporting of phase II and III clinical studies.
- Previous authoring/co-authoring of clinical trial protocols, ICFs, scientific trial-related documents is an advantage.
- Fluent in written and spoken English.
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