Provide medical, clinical and scientific advisory expertise. Participate in all aspects of Medical Science involvement on assigned trials.
Serve as a medical expert during project delivery lifecycle.
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.
May contribute to the medical review of the protocol, Investigative Drug Brochure (IDB) and / or Case Report Forms (CRFs).
May 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.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Current knowledge of scientific, clinical, regulatory, commercial and competitive landscape in applicable therapeutic area.
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. Attention to details, ability to provide advice on multiple assignments and flexibility.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
A medical degree along with a medical license, or equivalent, from the country or region in which he / she resides and works is required, plus a minimum of 5 years' experience in clinical medicine or equivalent combination of education, training and experience.
Prior clinical research experience is not required but desirable