肿瘤上市前医学医学监查肿瘤科医生 Essential Functions
● Medical Monitoring:
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.
Available 24/7 to respond urgent protocol -related questions from
investigative sites, in accordance with local labor laws.
● May require regular travel.
● Extensive use of keyboard requiring repetitive motion of fingers.
● Extensive use of telephone and face-to-face communication requiring accurate
perception of speech.
Qualifications
● Other Medical degree from an accredited and internationally recognized
medical school with a curriculum relevant to general medical education
● Typically requires a minimum of 5-7 years' experience in clinical medicine.
Req: Other Specialty board certification in relevant specialty area preferred.
Req
● Robust and 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.
● Business Acumen
● Other Current or prior license to practice medicine; Clinical experience in
the requested medical specialty. A board-certification for the required
therapeutic area is preferred.