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Job description :
Project Manager will serve as a team leader in the provision of major research activities. S/he will work closely with FHI research staff in country offices and headquarters and responsible for the coordination, technical support, management and implementation of clinical research studies.
Duties and Responsibilities :-
* Provides information tools for conduct research studies and functions as team leader in the provision of major research activities; including site training, project management, assisting with regional study implementation, clinical monitoring, paper/report writing.
* Coordinates and communicates with research staff in APRO, Country Offices, Headquarters, all network parties, sponsors in research studies implementations.
* Provides technical assistance and develop/initiate training curriculum and takes a leading role in provide training to Clinical Trial Support Specialist (CTSS), research assistants, interns, in-country colleagues, study staff and others as needed.
* Facilitates monitor follow up of monitoring visit by sponsor representative. Provides inputs and coordinates with Clinical Trial Support Specialists and sponsor in responding to monitoring reports.
* Reviews all reports and communication of study conduct to ensure compliance.
* Oversees regional study-specific reporting and tracking of key indicators for evaluation of site performance and study progress.
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Qualifications :
Qualifications :-
* BS/BA in Pharmaceutical, Medical Sciences or related field and 8-10 years relevant experience or
* MS in pharmaceutical, medical sciences or related field and 5-7 years relevant experience.
* Possess professional level of knowledge and expertise in clinical research method, Good Clinical Practice (GCP), and applicable research regulation and guideline.
* Experience in training, coaching of research staff.
* Be able to work with minimal supervision, manage high volume of work flow.
* Excellent written and verbal English language skills.
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