Job Description:
- 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.
Qualifications, knowledge, and Experience:
1.master’s degree or above in medical field, previous medical experience in CNS TA is a plus.
2.At least 10 years working experience in medical affairs, including central and regional medical experience.
3．Strategic thinking skills, the ability to successfully conceive, develop and act on plans.
4.Previous experience of medical excellence is preferred.
5.Excellent communication and interpersonal skills
