Job Description

Purpose:
Describe the primary goals, objectives or functions or outputs of this position.
Responsible for supporting the clinical development Neuroscience team with medical and safety monitoring.

Responsibilities:
List up to 10 main responsibilities for the job. Include information about the accountability and scope.
• 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 study team.
• Conducts literature reviews at the request of study teams

Qualifications:
List required and preferred qualifications (up to 10). Include education, skills and experience.
• MD/DO with 2+ years clinical development experience conducting medical monitoring for clinical trials.

What are the top 3-5 skills, experience or education required for this position:
1. Medical Monitoring experience (later stage trials preferred)
2. Excellent communication and interpersonal skills
3. Ability to work independently

Job Tags

Remote job, Contract work,

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