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Medical Monitor
Katalyst Healthcares & Life SciencesCambridge, MA25 days ago
Job type
- Full-time
Job descriptionMD / 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.
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 :
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Monitor • Cambridge, MA