Associate Medical Director/Medical Director - (US-NC-Durham - 27722)

Minimum Education: None
Job Type: Full Time
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Responsibilities : Provide medical surveillance on Serious Adverse Event (SAE) reporting and follow-up, including after hours coverage of medical emergencies Comply with all regulatory, sponsor, and Kendle guidelines for handling and reporting SAEs In consultation with the sponsor, follow procedures for breaking blind Interact with appropriate regulatory agencies concerning safety and other study related issues, as requestedMedical Monitoring With occasional assistance from more experienced Medical Monitor (Medical Director or Senior Medical Director), provide medical and scientific support to clinical research studies Review of preclinical and/or clinical data, study protocols, Investigator Drug Brochures, CRFs, etc. Develop study specific medical monitoring plan and reviews and approves Safety Project Plan. Assist with investigator recruitment by identifying proper investigator profile for study participation Monitor adherence to protocols and provide medical supervision and support for assigned clinical trials including on-call responsibilities. Review protocol deviations and approve waivers and exemptions when appropriate Interprets laboratory abnormalities or reference ranges, including panic and alert lab values Act as a liaison with sponsors, investigator sites, and Kendle project teams regarding study related medical/safety issues and resolution of study protocol and patient eligibility issues

Requirements :M.D. with at least three years of practical clinical experience and two years of clinical research experience. Familiarity and experience in clinical research data collection and computer systems is desired. Candidate/incumbent should have a complete understanding and application of principles, concepts, practices and standards in the CRO industry. Candidate/incumbent should be able to work concurrently on several projects, each with specific requirements that may differ from project to project. Excellent time management skills and decision-making skills are essential. Candidate/incumbent should be attentive to detail, flexible, open to suggestions, and possess excellent written and verbal communication skills. Candidate/incumbent should be able to interact with staff from multiple departments and Kendle offices.Kendle is an Equal Opportunity Employer.

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