12-month contract based in the UK
The Medical Monitor/Scientist will serve as a critical member of the clinical team, responsible for ensuring the integrity and quality of clinical data and supporting clinical oversight activities.
Key responsibilities include:
· Serving as a clinical team member assigned to data review for clinicians, including:
· Verification of subject eligibility based on medical history.
· Critical application of protocol-defined study requirements to assess data relevant to study endpoints (e.g., safety, tolerability, immunogenicity, efficacy).
· Reviewing serious and non-serious adverse events (AEs), including:
· Drafting and responding to site queries.
· Ensuring accurate and timely reconciliation of safety data.
· Reviewing reactogenicity data in eDiaries or EDC systems to ensure compliance with protocol-specified safety surveillance and monitoring.
· Assisting the lead clinician with:
· Aggregate data review and interpretation.
· Preparation and management of safety narratives.
· Slide development for internal and external presentations.
· Oversight or Participant in safety narrative authoring workflows.
· Supporting additional study-related tasks as required, such as:
· Review of training materials.
· Participating in safety surveillance meetings and contributing to PowerPoint creation as needed.
· Being available during normal business hours for the assigned region and working the specified number of hours per week.
· Additional responsibilities may be added based on prior experience, including study startup or conduct activities such as eDiary design, feasibility, informed consent document reviews, draft protocol reviews, safety presentations, and site interactions for safety follow up or protocol compliance and/or training.
Note: There is no interaction with regulatory authorities or direct contact with site staff in this role.