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职位概要 Job Highlights：
职责描述 Key Accountabilities：
1. Conduct pre feasibility and/or assess the feasibility of international/local protocols in his /her country
by collecting information and documentation on the study to be performed and by conducting surveys with opinion leaders, experts or potential investigators according to Clinical Study Director (CSD) and Feasibility Manager (FM) (Medical Operations) requirements and timing.
2. CSU preferred point of contact for Medical Operations to review and to provide medical input on proposed ES, protocol and/or Clinical Development Plan and medical practices in the country
3. Promote participation of the country for any clinical study.
4. Explore new investigational sites and develop high-productivity sites.
5. Maintain and expand the investigator network in his/her country.
B. SUPPORT TRIAL OPERATIONS
1. Validation of translations (i.e.: Protocol, CRF, amendments, Investigator Brochure, etc.) where applicable.
2. First-line medical support to the CSU team e.g.: answer medical questions from investigating sites, Ethics Committees, monitoring teams (MTs), study managers.
(should include also “appropriate” interaction with CSD and global team).
3. Support medical & scientific training to the monitoring team and others (including good understanding of material provided by the Global team
4. Support local Investigator Meetings regarding medical content, ethics and interaction with investigators.
5. Collaborate with MT to ensure achievement of country recruitment target, especially for medical aspect of the patients recruitmen strategy.
1. Make liaison for primary contacts with KOL and experts on behalf of CSDs
2. Represent the CSU at the scientific meetings/congresses, study IMs, meetings with disease associations
3. Provide key medical information to investigators and/experts in respect with communication policies (e.g study results, DMC advice, …)
Provide mentorship to junor MA as needed.
职能需求 Competence Profile：