临床试验医学肿瘤GCP医学监查医学策略 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.
●Participates in strategic business development activities including
presentations to prospective clients.
●Maintains awareness of industry development and may author related
publications.
● Requires periodic regional and international travel.
Qualifications
● Other 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.
● Other Specialty board certification in relevant specialty area preferred
● 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
coworkers, 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. A board-certification for the required
therapeutic area is preferred.