Associate Medical Director Infectious Disease
The Associate Medical Director, Infectious participates in all aspects of Medical and Scientific Services' involvement on assigned trials in the infectious arena across APAC. Assists in the implementation from global on department mission, goals and objectives, oversight of operations, development of policies and procedures and standards for the department.
- 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 review and clarification of trial-related Adverse Events (AEs).
- Performs medical case review of Serious Adverse Events, including review of case documentation and patient narrative.
- Provides medical support for the Analysis Of Similar Events (AOSE).
- Performs medical review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs).
- Performs review of the Clinical Study Report (CSR) and patient narratives.
- Attends and presents at Investigator Meetings.
- Provides therapeutic area/indication training for the project clinical team.
- Participates in management level meetings within Medical and Scientific Services.
- Provides support to the proposal development team which may include, but is not limited to, reviewing the protocol for feasibility, giving guidance as to anticipated enrolment, and general advice as to the various risks associated with running a particular study.
- Participates in development of Medical and Scientific Services portion of client proposals including the budgeting process.
- Serves as a resource, and may participate in strategic business development activities including presentations to prospective clients, professional meetings, and other business development activities for Medical & Scientific Services.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Desired Skills and Experience
- Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research including knowledge of regulations and guidelines pertaining to regulatory affairs
- Ability to establish and meet priorities, deadlines, strategic department goals and objectives.
- Skills in providing consultation and advice on multiple assignments required, as well as initiative and flexibility.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
- Regional APAC experience
- MD/PhD required
To apply, please email CV at r.nainan @ realstaffing.com , or call 65 6871 4700 for further information.
License No: 09C5506
Real Staffing Group Reg No: 53132073A
SThree Pte Ltd Business Reg No: 200720126E
Real, a trading division of SThree Pte Limited (Registration Number: 2007.20126E | SThree Pte Limited Licence Number 16S8216 | Real Licence Number 53132073A)
Award winner of:
International Recruitment Company of the Year by Recruitment International 2016
Life Sciences and Healthcare Recruitment Company of the Year by Recruitment International 2016
Best Overseas Operation by Global Recruiters 2017
Highly Commended for Best Large Recruitment Business 2017