Medical Monitor

Medical Monitor – Psychiatry / Neurology9-month contractRemote - some travel required to Princeton, NJWe are hiring a Medical Monitor with 6+ years of clinical drug development experience to support Phase 2 and Phase 3 Psychiatry and Neurology programs.This role combines medical monitoring, clinical data review, safety evaluation, and regulatory document support. You will work closely with Clinical Operations, Biometrics, Pharmacovigilance, Regulatory Affairs, and CRO partners across ongoing and upcoming studies.What You’ll Work OnReview safety and efficacy data from Phase 2 and Phase 3 studiesIdentify and assess emerging safety signalsSupport medical data review, data cleaning, and query resolutionReview SAEs and communicate with study sites as neededContribute to protocols, CSRs, ISS/ISE documents, IBs, DSURs, and regulatory submissionsSupport protocol interpretation and study conduct during trial executionPartner with CROs on data review, reporting, and trial management activitiesParticipate in Safety Review Team and cross-functional development meetingsBackground RequiredMD or equivalent physician qualification6+ years of clinical development experiencePsychiatry or Neurology experience requiredExperience supporting Phase 2 and/or Phase 3 studiesExperience reviewing clinical safety and efficacy dataExperience contributing to regulatory submission documents and clinical study reportsPreferredCNS development experienceFDA or global regulatory submission experienceExperience in biotech or small-to-mid-sized pharma environmentsISS/ISE and safety document experience