You will support compliance with protocol execution from a medical and scientific perspective. You will provide medical expertise during project delivery lifecycles; provide medical support to project teams and investigative sites; clarify protocols and inclusion/exclusion determinations; advise around patient safety issues; perform medical reviews and clarifications of trial-related and post marketing studies Adverse Events; signal detection and aggregated reporting; and conducting project delivery lifecycles (pre-marketing and post-marketing).

Responsibilities:

• Primarily acts as back-up Medical Advisor but may serve as Regional Medical Advisor on assigned projects.
• Provides medical support to investigative sites and project staff for protocol-related issues including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility.
• Contribute to the medical review of the protocol, Investigative Drug Brochure (IDB) and/or Case Report Forms (CRFs).
• Provide therapeutic area/indication training for the project clinical team.
• Attends and may present at Investigator Meetings.
• Performs review and clarification of trial-related Adverse Events (AEs).
• May perform medical case review of Serious Adverse Events (SAEs), including review of case documentation and patient narrative, in collaboration with the Pharmacovigilance department.
• May provide medical support for the Analysis of Similar Events (AOSE), in collaboration with or on behalf of Pharmacovigilance department.
• May perform medical review of adverse event coding.
• Performs review of the Clinical Study Report (CSR) and patient narratives.
• Attends Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.
• Available 24 hours per day, 7 days per week to respond to urgent protocol-related issues at the investigative sites.

Qualifications:

• Medical degree with training in Hematology or Oncology from an accredited and internationally recognized medical school with a curriculum relevant to general medical education.
• Specialty Board certification in relevant specialty area preferred.
• Some years of prior relevant experience in general clinical medicine including experience in the requested applicable medical specialty area or equivalent combination of education, training, and experience.
• Current knowledge of medical, scientific and clinical landscape in applicable therapeutic area.
• Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research.
• Strong communication, presentation and interpersonal skills, including good command of English language (both written and spoken).
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• May require occasional travel.

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