Medical Monitor Job at cGxPServe, Cambridge, MA

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  • cGxPServe
  • Cambridge, MA

Job Description

Responsibilities:

  • Responsible for supporting the clinical development Neuroscience team with medical and safety monitoring.
  • Provides medical monitoring and observation of clinical trials to ensure safety and adherence to protocol.
  • Coordinates, conducts, and communicates overview of safety data and significant changes to the study team.
  • Provide medical review, comment and assessment of causality for Serious Adverse Events (SAEs).
  • Responsible for medical monitoring of assigned studies including data reviews, queries assigned in TESLA.
  • Participates in Product Safety Team meetings.
  • Reviews CSRs/IBs/submissions, etc.
  • Peer review draft DRC materials.
  • Monitor and compile competitive intelligence (landscape) assessments/white papers and provide medical perspective/implications.
  • Assesses start-up requirements for EDC to ensure studies are set up properly for medical monitoring in collaboration with the study team.
  • Conducts literature reviews at the request of study teams.

Requirements:

  • MD/DO with 2+ years clinical development experience conducting medical monitoring for clinical trials.
  • Medical Monitoring experience (later stage trials preferred).
  • Excellent communication and interpersonal skills.
  • Ability to work independently.

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