Clinical Development Services Agency (CDSA) is an extramural unit of Translational Health Science and Technology Institute (THSTI) and has been established as a not-for-profit society to provide cost affective, high quality preclinical and clinical product development support services to meet the country’s growing healthcare needs. It will tend enterprises; particularly SMEs involved in new technology innovation and facilitate translation of scientific know-how into viable products.

Post : Project Coordinator (Non-Medical) (iKMC Study), 01 (one)

Age Limit Upto 45 Years

Emoluments/ Duration : Rs. 75,000/- per month consolidated, 30 Months

Location : Safdarjung Hospital, New Delhi

Job profile
Support Medical Director for overall system and processes set-up for efficient management of the SOW for the project. General areas of responsibility include:

1. Administratively manage assigned Clinical Study at the site
2. Leads planning and execution of start-up activities including preparation of study related documents.
3. Adhere to Study Protocol & Site SOP
4. Ensure that Non- Serious and Serious Adverse Events are properly documented and reported
5. Responsible for maintenance of the subject’s medical records for completeness and accuracy
6. Responsible for scheduling follow-up visits of research staff
7. Liaise with cross-functional departments / teams for study related tasks
8. Plan and oversees infrastructure and human resource requirement and on-boarding process of the project staff.
9. Provide administrative support to Team Lead and liaise with Administration, Finance and other departments.
10. Act as communication channel between Director-Medical and Team Leads of the project
11. Managing study-related vendors and serving as the primary point of contact for contracted vendors, study staff and contract labs; identifying potential risks and resolving issues with vendors; establishing vendor management plans and reviewing quality metrics.
12. Organizes and coordinate project meetings such as Investigator Meeting, Advisory Boards Meeting etc.
13. Coordinate with Team Leads and Finance Department to keep track of budgetary expenditures and payments.
14. Keep track and report (to Director Medical) of regular progress of projects and compliance to site visit report timelines of study
15. Providing support to sites to prepare for clinical audits and to respond to audit findings conducted by internal QA and external agencies
16. Work with other internal departments on their requirements as and when required

Qualifications and Experience
Allied Medical degree or Masters in medical sciences, public health human life sciences, pharmacy, healthcare or other related discipline with 7 years of relevant experience in clinical trials / research projects. At least 03 years of Project Management or Management experience recommended (includes time spent as functional Primary or functional/technical Lead)

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