Remote Associate Medical Director

Proclinical is currently recruiting for an Associate Medical Director for a global CRO located in Raleigh, NC. Successful candidate will work with an international team of medical monitors and safety officers to ensure the medical/clinical integrity and quality of studies are conducted in compliance with all applicable competent authority regulations and international Good Clinical Practices (GCP).

Job Responsibilities:

• Oversee the safety aspects of assigned clinical trials including adverse events, safety reporting and laboratory testing. Assist the Project Manager in discussions with clients on safety issues or concerns that may have arisen.
• Prepare the Medical Monitoring and other relevant Plans prior to the start of the study.
• Serve as the medical monitor contact in study protocols.
• Reviews IND safety narratives in accordance with FDA and ICH E2 reporting standards and oversees the processing of SAEs, SUSARs, etc. to clients and to regulatory agencies.
• Provide ongoing tutoring/medical education to DSOs, Regulatory, Clinical Operations personnel and other team members.
• Provide 24/7 monitoring coverage as required for the assigned protocols.
• Review and address all medical alerts setup for the safety of assigned projects.
• Review clinical laboratory data on selected studies for safety tends or signals detection.
• Assist clinical data management with MedDRA and WHO coding.
• Conduct the medical reviews of safety listings and clinical trial data in assigned studies.
• Assist by reviewing or writing safety section of a CSR and other safety reports including post marketing reports.
• Review Investigational Brochures, protocols or other study-related documents.
• Assist in the set up and conduct of Data Safety Boards.

Skills and Requirements:

• MD or DO Degree required.
• 2+ years' medical monitoring experience and/or relevant clinical research experience.
• Able to make medical decisions for the study independently and can act as primary medical monitor on assigned studies.
• Able to review relevant medical documentation to give assistance to Business Development.
• Previous experience within a clinical and research environment, preferably CRO.
• High level of Organizational and technology skills.
• High level of interpersonal and presentation skills.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Brendan Dunn at (+1) 646-481-1930 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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