Medical Monitor

About the role

Celerion is seeking a physician‑level Medical Monitor to provide medical oversight for early‑phase clinical trials conducted in its Clinical Pharmacology Units. The role ensures participant safety throughout study conduct, from screening to dosing and confinement periods.

Key responsibilities

• Provide on‑call medical coverage during screening, check‑in, dosing, and confinement for Phase I, first‑in‑human and healthy volunteer studies.
• Review and approve subject eligibility based on medical history, physical exam, labs, ECGs and protocol criteria.
• Respond to medical emergencies and adverse events, directing escalation and emergency management as needed.
• Participate in Safety Review Committee meetings, offering medical input on dose‑escalation decisions for FIH, MAD and SAD studies.
• Review real‑time safety data (vital signs, labs, ECGs, PK data) to inform stopping rules and dose‑escalation criteria.
• Review protocols, informed consent forms and safety monitoring plans for medical accuracy and regulatory compliance.
• Collaborate with investigators, research coordinators, nursing staff and pharmacovigilance teams.

Required profile

• Medical degree with experience in early‑phase (Phase I) clinical trials.
• Strong knowledge of GCP, ICH guidelines and FDA 21 CFR regulations.
• Ability to make rapid clinical decisions during dosing and confinement periods.
• Experience reviewing safety data, including PK and ECG results.
• Excellent communication skills for interaction with sponsors, investigators and IRBs.

Required skills

• Good Clinical Practice (GCP)
• ICH guideline expertise
• FDA 21 CFR regulatory knowledge
• Pharmacokinetic (PK) data interpretation
• ECG interpretation

What we offer

• Opportunity to work with a leading CRO specializing in early‑phase drug development.
• Collaborative environment with cross‑functional scientific teams.
• Exposure to innovative translational medicine projects.