In this contract medical monitor role, the clinician will support late-stage clinical development by reviewing trial data, interpreting safety and efficacy findings, and helping guide study conduct and protocol execution. The work also includes authoring and reviewing regulatory and clinical documents, such as study reports, safety updates, investigator materials, and submission content. This is a remote position with EST hours and a strong focus on cross-functional collaboration with clinical development, biometrics, regulatory affairs, pharmacovigilance, and CRO partners.
Key Responsibilities
- Provide clinical development support across late-stage programs, including scientific review and interpretation of clinical data.
- Review and interpret clinical trial data, including tables, listings, and figures.
- Support medical data review, data cleaning, and issue resolution with internal teams and CROs.
- Analyze safety and efficacy data, including post hoc and exploratory analyses.
- Author, review, and finalize clinical and regulatory documents, including CSRs, ISS, ISE, IB updates, DSURs, and submission materials.
- Contribute to clinical protocols, protocol amendments, informed consent forms, and clinical trial plans.
- Provide clinical guidance on protocol interpretation and study conduct during trial execution.
- Participate in safety review meetings and support benefit-risk assessments and safety documentation.
Required
- MD or DO degree.
- At least 5 years of drug development experience in the pharmaceutical or biotechnology industry.
- Experience serving as a Medical Monitor or supporting clinical development programs.
- Experience reviewing clinical trial safety and efficacy data.
- Experience authoring and reviewing clinical and regulatory documents.
- Experience collaborating with cross-functional teams and CRO partners.
Preferred
- Experience supporting late-stage clinical development programs.
- Nephrology therapeutic area experience.
- Immunology therapeutic area experience.