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:
- Administratively manage assigned Clinical Study at the site
- Leads planning and execution of start-up activities including preparation of study related documents.
- Adhere to Study Protocol & Site SOP
- Ensure that Non- Serious and Serious Adverse Events are properly documented and reported
- Responsible for maintenance of the subject’s medical records for completeness and accuracy
- Responsible for scheduling follow-up visits of research staff
- Liaise with cross-functional departments / teams for study related tasks
- Plan and oversees infrastructure and human resource requirement and on-boarding process of the project staff.
- Provide administrative support to Team Lead and liaise with Administration, Finance and other departments.
- Act as communication channel between Director-Medical and Team Leads of the project
- 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.
- Organizes and coordinate project meetings such as Investigator Meeting, Advisory Boards Meeting etc.
- Coordinate with Team Leads and Finance Department to keep track of budgetary expenditures and payments.
- Keep track and report (to Director Medical) of regular progress of projects and compliance to site visit report timelines of study
- Providing support to sites to prepare for clinical audits and to respond to audit findings conducted by internal QA and external agencies
- 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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Skills
- Leadership skills that include ability to build effective project teams, ability to motivate others, delegation, drive and timely/ quality decision making
- Personal qualities that include the ability to gain trust and confidence with stakeholders.
- Operational skills including focus and commitment to quality management and problem solving
- Influencing skills including negotiation and teamwork
- Effective communication skills that Include the provision of timely and accurate information to stakeholders
- Understanding of GCP guidelines
- Excellent Computer skills (MS Word, excel, internet)
- Knowledge of adverse medical event investigation, analysis, and reporting procedures and standards
GENERAL TERMS & CONDITIONS:
1. All educational professional and technical qualification should be from a recognized Board/ University and full-time.
2. The experience requirement specified should be experience acquired after obtaining the minimum educational qualifications required for the post.
3. Persons working in Govt. or Public Sector undertaking should produce “No Objection Certificate” at the time of Interview.
4. The qualification, experience and other requirements for the posts are relaxable at the discretion of the competent authority, in case of candidates who are otherwise suitable. Candidates not found suitable for the posts notified, can be offered a lower post on the recommendation of the Selection Committee.
5. No TA/DA will be admissible to appear in the interview, including (SC/ST candidates).
6. Only candidates who can join immediately needs to apply, as the position is to be filled on an urgent basis.
7. This position will be purely on temporary/contractual basis for the specified period of time and based on project.
8. In case large number of applications are received for each post, screening will be done to limit the number of candidates to those possessing higher/relevant qualification.
9. Only shortlisted candidates will be called for Written test/Interview. Request for change in Written test/ Interview schedule will not be entertained under any circumstances.
10. The salary is a consolidated sum without any other benefits and it is based on experience, qualifications, skill set, etc. of the candidates.
11. Interested candidates may please send their current CV along with the application form (attached on CDSA website) with a recent color photo and cover letter indicating their motivation for the position applied for in 150 words and three references by e-mail with subject line mentioning “Application for the position “Project Coordinator (Non- Medical) (iKMC Study)” to cdsa_admin@thsti.res.in.
12. Incomplete applications will stand summarily rejected without assigning any reasons thereof.
13. All results will be published on our website and all future communications will be only through email.
14. Canvassing in any form will be a disqualification.
Applications will be accepted up to 15th October 2017.
Note: In case a suitable candidate is not found, the call for application will remain open till suitable candidate is found. As soon as suitable candidate is found, this recruitment notice will be closed on our website.
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