Katalyst CRO
Join to apply for the Medical Director I role at Katalyst CRO .
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Join to apply for the Medical Director I role at Katalyst CRO .
- 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.
- Provides medical review, comments, and assessments of causality for Serious Adverse Events (SAEs).
- Responsible for medical monitoring of assigned studies including data reviews and queries in TESLA.
- Participates in Product Safety Team meetings.
- Monitors and compiles competitive intelligence assessments/white papers and provides medical perspectives and implications.
- Assesses start-up requirements for EDC to ensure studies are properly set up for medical monitoring in collaboration with the study team.
- Conducts literature reviews at the request of study teams.
Responsibilities
- Supports clinical development Neuroscience team with medical and safety monitoring.
- Provides medical monitoring and observation of clinical trials to ensure safety and protocol adherence.
- Coordinates, conducts, and communicates safety data overview and significant changes to the study team.
- Reviews and assesses causality for Serious Adverse Events (SAEs).
- Monitors assigned studies, including data reviews and queries in TESLA.
- Participates in Product Safety Team meetings.
- Reviews CSRs, IBs, submissions, etc.
- Peer reviews draft DRC materials.
- Prepares landscape assessments/white papers and provides medical insights.
- Ensures proper setup for medical monitoring during study start-up, collaborating with the study team.
- Conducts literature reviews as requested.
Requirements
- MD/DO with 2+ years of clinical development experience conducting medical monitoring for clinical trials.
- Experience in medical monitoring, preferably in later-stage trials.
- Excellent communication and interpersonal skills.
- Ability to work independently.
Seniority level
- Associate
Employment type
- Contract
Job function
- Health Care Provider
Industries
- Pharmaceutical Manufacturing