Senior Associate at APCER Life Sciences
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Drug Safety Physician - Hospital - MD (1-4 yrs)
Medical Monitoring
- Provide medical oversight regarding protocol exemptions, protocol violations, protocol eligibility issues, accepted medications, and general medical-related study issues
- Review laboratory alerts, and coordinate appropriate follow-up with study site
- Conduct training for the project team concerning the disease, drug, study design and procedures
- Provide consultation to the study team during review of out-of-range laboratory values for clinical and /or protocol significance
- Preview listings of AEs/SAEs, study withdrawal/Discontinuation, lab reports, and subject profiles as defined within the Safety Medical Monitoring Plan
- Participation in DSMB meeting, review and provide the data and inputs for the same
- Ensure all protocol inquires and answers are documented
- Additional tasks may involve attendance and participation at Investigator Meetings, preparation of subject narratives, review of study reports and other documents, preparation and/or review of periodic and interim safety reports
- Conduct a medical review of the Project Plan, Tables and Listings, and the Integrated Clinical Study Reports as appropriate
- Monitoring the work progress, ensure timely delivery, participating in status meetings, updating project progress to the stakeholders
- Liaise effectively and maintain excellent relationship with the clients and external contacts.
- Trains and mentors new employees (if required)
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