USA - Exception - Clinical-Scientific - USD

ROLE RESPONSIBILITIES
The Medical Monitor Contractor 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 (, 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:

•...