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)

This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.