Medical Monitor
Medical Monitor – Psychiatry / Neurology
9-month contract
Remote - some travel required to Princeton, NJ
We 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 On
• Review safety and efficacy data from Phase 2 and Phase 3 studies
• Identify and assess emerging safety signals
• Support medical data review, data cleaning, and query resolution
• Review SAEs and communicate with study sites as needed
• Contribute to protocols, CSRs, ISS/ISE documents, IBs, DSURs, and regulatory submissions
• Support protocol interpretation and study conduct during trial execution
• Partner with CROs on data review, reporting, and trial management activities
• Participate in Safety Review Team and cross-functional development meetings
Background Required
• MD or equivalent physician qualification
• 6+ years of clinical development experience
• Psychiatry or Neurology experience required
• Experience supporting Phase 2 and/or Phase 3 studies
• Experience reviewing clinical safety and efficacy data
• Experience contributing to regulatory submission documents and clinical study reports
Preferred
• CNS development experience
• FDA or global regulatory submission experience
• Experience in biotech or small-to-mid-sized pharma environments
• ISS/ISE and safety document experience
9-month contract
Remote - some travel required to Princeton, NJ
We 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 On
• Review safety and efficacy data from Phase 2 and Phase 3 studies
• Identify and assess emerging safety signals
• Support medical data review, data cleaning, and query resolution
• Review SAEs and communicate with study sites as needed
• Contribute to protocols, CSRs, ISS/ISE documents, IBs, DSURs, and regulatory submissions
• Support protocol interpretation and study conduct during trial execution
• Partner with CROs on data review, reporting, and trial management activities
• Participate in Safety Review Team and cross-functional development meetings
Background Required
• MD or equivalent physician qualification
• 6+ years of clinical development experience
• Psychiatry or Neurology experience required
• Experience supporting Phase 2 and/or Phase 3 studies
• Experience reviewing clinical safety and efficacy data
• Experience contributing to regulatory submission documents and clinical study reports
Preferred
• CNS development experience
• FDA or global regulatory submission experience
• Experience in biotech or small-to-mid-sized pharma environments
• ISS/ISE and safety document experience