My client, a global biopharmaceutical business is seeking an excellent Clinical Trial Scientist (Clinical Trial Specialist) to join the business on a 12 month contact basis to sit within the Clinical Development division.
Key Responsibilities include:
- All tasks are performed in compliance with GCP and the company’s SOPs.
- Depending on level of experience, they may contribute to the following trial-level activities in collaboration with a more experienced trial scientist.
- Core member of the clinical trial team (CTT)
- Collaborates closely with the Clinical Trial Physician (CTP) on relevant trial-related activities
- Develops a sound understanding of the science and medicine related to an indication and trial and performs literature searches as needed to keep knowledge up to date
- Main deliverables include the clinical trial protocol and related documents such as the ICF, study committee charters, study guidelines/instructions, PD code list, subject narratives, and the CSR
- Provides input into and reviews cross-functional trial documents such as the SAP, ESP requirements and specifications, monitoring guidelines, data review manual
- Performs data review and medical monitoring during the conduct of the trial
- Coordinates/manages the study committees
- Provides scientific input into responses for IRBs/ECs and Has
- Participates in discussions with external experts
- Trains the relevant functions and roles on the scientific aspects of the trial
- Contributes to cross-functional and clinical development initiatives and processes as needed
- PhD, Pharm D, MSc or equivalent university degree in life or health sciences
- At least 2 years of working experience preferably in clinical development in a contract research organization (CRO) or pharmaceutical company
- Previous experience in either the planning, set-up, conduct, closing, and reporting of phase II and III clinical studies from a scientific perspective is an asset
- Fluent in English (written and oral), good organizational, problem solving, and interpersonal and communication skills
- Ability to work independently and within a cross-functional team to prioritize and coordinate multiple competing tasks
If this role sounds of interest, please get in contact with me at
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