Job Description

Job Summary

Seeking a Medical Monitor to serve as the primary point of contact for medical and drug safety matters across multiple clinical trials (all phases) supporting pharmaceutical development and regulatory submissions. This role collaborates closely with internal teams, CROs, and contractors, and plays a key part in ensuring trial safety, compliance, and data integrity.

Responsibilities

• Oversee clinical trials for participant eligibility, safety, and adherence to protocol
• Review safety data, identify trends or issues, and recommend trial adjustments
• Provide medical input on study design, protocols, and regulatory documents
• Support safety signal detection, benefit-risk assessments, and regulatory filings (e.g., NDA, MAA, RMP)
• Ensure compliance with global regulatory and ethical standards
• Manage safety reporting activities (AEs, SAEs, SUSARs) and lead investigations
• Collaborate with clinical operations to maintain high data quality
• Provide safety training and protocol guidance to staff and investigators
• Report trial performance metrics to senior leadership

Qualifications

• MD, DO, or PharmD in a relevant scientific discipline
• 3–5 years as a Medical Monitor in biotech/pharma
• Strong background in drug safety, pharmacovigilance, and clinical development
• In-depth knowledge of FDA, EMA, and ICH-GCP guidelines
• Proven ability to manage multiple projects in a fast-paced environment

Interviews next week, apply now!

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