• Primarily serves as Global Medical Advisor on assigned projects.
• Serves as Scientific Advisor and provides guidance to Project Leaders on the medical and scientific aspects of 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.
• Performs medical review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs).
• Provides therapeutic area/indication training for the project clinical team.
• Attends and presents 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.

• May contribute to the development of the medically related section of client proposals, including the budgeting process. 
• May provide medical and scientific advises to key internal stakeholders developing proposals: this may include, but is not limited to, protocol feasibility, identification of target site and principal investigator profiles, anticipated patient recruitment, standard of care and competitive landscape.
• May attend and present at bid defense meeting, as required. 
• Maintains awareness of industry development.

• Current knowledge of scientific, clinical, regulatory, commercial and competitive landscape in applicable therapeutic area. 
• Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research. 
• Good 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. 
• Skills in providing consultation and advice on multiple assignments are required, as well as initiative and flexibility.