Job Summary
- Company
- Kendle International
- Location
- durham, NC 27701
- Industries
- All
- Job Type
- Full Time
- Employee
- Education Level
- Doctorate
- Career Level
- Experienced (Non-Manager)
- Job Reference Code
- PCK413-16056
Associate Medical Director/Medical Director
About the Job
job ID: 6350
Position Title: Associate Medical Director/Medical Director
Working Location: Durham, North Carolina
Employment Status: Full-Time Regular
Required Experience: 3 years
Required Education: Doctorate Degree
Required Travel: 0
Job Summary:
Medical Director's at Kendle provides medical and safety support to clinical research teams, investigators, and study staff. This position will also support the New Business Development team.
Core Responsibilities:
The Associate Medical Director’s role is to verify the medical accuracy of patient safety data and to maintain an ongoing assessment of the safety profile of the study
• Review serious adverse experience data, primary and secondary safety and efficacy data on a regular basis. 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 requested
Medical 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
• Provides medical review and editing of clinical study reports. Review clinical data, listings, tables, and codes for medical consistency, interpretation and coherence
• Serves as medical liaison to company Institutional Review Board(s)
• Presents study material at various physician conferences, e.g. Investigator Meetings
Training Activities
• Assist with training of clinical research staff, including in-servicing of project related material on various therapeutic areas
• Present training and educational seminars to company, sponsors and investigator staff
Secondary Duties and Responsibilities
• Assist to Business Development with proposal development
• Establish and maintains a network of medical/scientific consultants, etc.
• Participate in a variety of team quality improvement efforts as necessary
• Ability to travel
• Other duties and assignments as requested for the overall performance of the department and the company
Skills & Attributes:
The Candidate/incumbent should have a 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.
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Company Tools
Contact Information
Kendle International
