Medical Monitor, Clinical Trials
Medical Monitor, Clinical Trials
Company: Global Biopharmaceutical Company
Company Location: Philadelphia, PA
Work Arrangement: Remote, United States
Engagement: Contract Consulting Role
The Opportunity
Brio Resource Group is partnering with a global biopharmaceutical company to identify an experienced Medical Monitor, Clinical Trials.
This consulting position will provide medical oversight across assigned clinical studies, supporting participant safety, consistent protocol interpretation, and high-quality trial execution. The successful consultant will serve as a medical resource to study teams, investigators, and cross-functional partners throughout study conduct.
Key Responsibilities
- Provide medical oversight for assigned clinical trials and serve as the primary medical resource for study teams and investigators.
- Review adverse events, serious adverse events, laboratory findings, vital signs, ECGs, and other clinically significant safety data.
- Evaluate participant eligibility and advise investigators and study teams on inclusion and exclusion criteria.
- Respond to protocol, medical-management, and study-conduct questions from investigators and clinical teams.
- Identify emerging safety trends and recommend appropriate follow-up, escalation, or risk-mitigation actions.
- Collaborate with Pharmacovigilance and Drug Safety on event assessment, causality, expectedness, and reporting requirements.
- Support protocol development, amendments, informed-consent materials, investigator brochures, and medical-monitoring plans.
- Contribute to safety-review meetings, data-review committees, investigator meetings, and study-team discussions.
- Document medical-review activities and ensure decisions are consistent, traceable, and compliant with study requirements.
- Provide medical input into clinical study reports, aggregate safety reviews, regulatory submissions, and responses to health authorities.
- Partner with Clinical Development, Clinical Operations, Biometrics, Regulatory Affairs, and external CROs.
- Support study training and ensure consistent medical and protocol interpretation across sites and regions.
Qualifications
- MD, DO, or equivalent medical qualification with relevant clinical experience.
- Experience providing medical monitoring for industry-sponsored clinical trials.
- Strong knowledge of participant safety, protocol interpretation, adverse-event assessment, and benefit-risk evaluation.
- Working knowledge of ICH-GCP, clinical-development processes, and global regulatory requirements.
- Experience reviewing clinical, laboratory, safety, and efficacy data.
- Ability to provide timely, practical medical guidance to investigators and cross-functional study teams.
- Strong medical writing, documentation, communication, and decision-making skills.
- Experience collaborating with Clinical Operations, Pharmacovigilance, Biometrics, Regulatory Affairs, and CRO partners.
- Ability to work independently and manage multiple studies or competing priorities within a remote environment.
- Therapeutic-area expertise aligned with the assigned clinical programs is preferred.
Why Consider This Opportunity?
This engagement offers the opportunity to provide meaningful medical leadership within a global clinical-development organization, support participant safety across important clinical programs, and collaborate with experienced investigators and cross-functional partners throughout the trial lifecycle.
Additional information regarding the company, therapeutic area, contract duration, weekly allocation, compensation, and engagement structure will be provided following an initial résumé review.
