Essential Functions
The role includes predominantly Medical Monitoring responsibilities with Medical Strategic input involvement as requested.
Medical Monitoring:
Primarily serves as Global and /or Regional 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.
Available 24/7 to respond urgent protocol -related questions from investigative sites, in accordance with local labor laws.
Medical Strategy:
Provides expert advises to the development of medically sounded delivery strategies for small to large and/or complex multi-region studies in partnership with sales and other functions responsible for business development activities.
Responsible for the development of the medically related aspects of client proposals including the budget related to medical monitoring.
Provides medical and scientific advises to key internal stakeholders developing proposals: this may include, but is not limited to, reviewing the protocol for scientific/regulatory soundness and feasibility, identification of target site and principal investigator profiles, anticipated patient recruitment, standard of care and competitive landscape.
Attends and presents at bid defense meeting, as required.
Medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education, plus a minimum of 5 years' experience in clinical medicine.
Typically requires 5 – 7 years of prior relevant experience in general clinical medicine including experience in the requested applicable medical specialty area; In addition, previous clinical research experience as an investigator or in the Pharma, CRO, or Biotech industry is required or equivalent combination of education, training and experience
Ability to establish and maintain effective working relationships with co-workers, managers and clients.
Strong communication, presentation and interpersonal skills, including good command of English language (both written and spoken).
Robust and current knowledge of scientific, clinical, regulatory, commercial and competitive landscape in applicable therapeutic area.
Proven skills in providing consultation and advice on multiple assignments are required, as well as initiative and flexibility.
Other Current or prior license to practice medicine; Clinical experience in the requested medical specialty.
Board Certified- C המשרה מיועדת לנשים ולגברים כאחד.
