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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