Summary:he Medical Monitor Contractor will serve as a critical member of the clinical team, responsible for clinical data review, safety surveillance, and medical oversight activities supporting interventional clinical studies. This role requires a medically qualified professional with strong clinical judgment, prior medical monitoring experience, and the ability to critically evaluate safety and efficacy data in a fast-paced research environment.
The successful candidate will contribute to ensuring the integrity, quality, and timely review of clinical trial data while supporting study teams with safety assessments, data interpretation, and operational activities.
Roles & Responsibilities:- Clinical Data Review & Medical Monitoring
- Serve as a clinical team member responsible for ongoing data review and medical monitoring activities.
- Verify participant eligibility based on medical history and protocol requirements.
- Apply protocol-defined study criteria to assess data relevant to safety, tolerability, immunogenicity, efficacy, and other study endpoints.
- Review serious adverse events (SAEs) and non-serious adverse events (AEs), ensuring accurate medical assessment and documentation.
- Draft, review, and respond to site queries related to safety and clinical data.
- Ensure accurate and timely reconciliation of safety data.
- Review reactogenicity and other safety-related data captured in eDiaries, EDC systems, and other clinical databases to ensure compliance with protocol requirements.
- Safety Oversight
- Support aggregate safety data review and interpretation.
- Assist in the preparation and management of safety narratives.
- Participate in safety surveillance activities and safety review meetings.
- Contribute to safety presentations and PowerPoint development for internal and external stakeholders.
- Support safety narrative authoring workflows and related documentation processes.
- Study Support Activities
- Conduct literature reviews and medical research as needed.
- Support data cleaning and data quality initiatives.
- Review training materials and study documentation.
- Assist with study startup, study conduct, and operational activities based on prior experience.
- Contribute to protocol reviews, informed consent document reviews, feasibility assessments, and study-related medical input.
- Support eDiary design and review activities when applicable.
- Collaboration & Team Support
- Work closely with clinicians, study leadership, and cross-functional clinical teams.
- Provide medical expertise to support study execution and data quality.
- Be available during standard business hours and work the agreed-upon schedule.
- Perform additional study-related responsibilities as assigned.
Note: This role does not include interactions with regulatory authorities and does not involve direct contact with study site staff.
Required Qualifications :- Medical Degree (MD, DO, MBBS, or equivalent).
- Minimum of 2 years of independent clinical practice experience post-residency.
- Minimum of 2 years of medical monitoring experience within clinical research.
- Experience reviewing safety data, including serious and non-serious adverse events.
- Experience supporting interventional clinical trials within the last 3 years.
- Strong understanding of clinical trial design, conduct, and execution.
- Ability to critically evaluate complex medical and scientific information.
- Experience reviewing clinical data involving pediatric, adult, and obstetrical populations.
- Proficiency with Microsoft Word, Excel, and PowerPoint.
- Excellent written and verbal English communication skills.
- Ability to work independently and adapt in a fast-paced environment.
- Preferred Qualifications
- Previous experience supporting Pharmaceutical clinical studies or familiarity with large pharmaceutical company processes.
- Vaccine clinical trial experience.
- Experience in infectious diseases, infection control, or related therapeutic areas.
