Clinical Development Services Agency (CDSA) mission is to create, develop, nurture world class clinical product development capacity in India.
Emoluments & duration of assignment :
Maximum up to Rs 85,000/- per month (Six Months)
Location : CDSA Office, Faridabad
Job profile :
Support Clinical Portfolio Management department for overall sytem and processes set-up for efficient management of the SOW for new and sanctioned clinical studies or clinical programs. General areas of responsibility include:
- Assist in feasibility assessments of project proposals, budget, scope, and timelines.
- Liaise with cross-functional departments / teams for preparation of proposals and coordinate negotiations with the stakeholders.
- Leads planning and execution of start-up activities including preparation of regulatory and technical documents.
- Plan and oversees infrastructure and human resource requirement and on-boarding process of the project staff.
- Preparation and review of project management tools and documents such as Project Management Plan, Clinical Operation Plan, Monitoring Manuals and Risk Management Plan etc.
- Takes responsibility of Quality management, training & development and review of departmental Standard Operating Procedures (SOPs) and conduct of regular trainings / orientation sessions for clinical staff on regular basis.
- Provide administrative support to Team Leads and liaise with Administration, Finance and other departments.
- Act as communication channel between Director-CPM and Team Leads of the projects which includes issue escalation procedure.
- 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.
- Assume responsibility of Team Lead until hiring of project specific Team Lead.
- Plans and execute assessment, scope, negotiations and deployment of project management / clinical management tools and information technology platforms such as Clinical Trial Management System, Document Management Systems, eCRF tools etc.
- Coordinate with Team Leads and Finance Department to keep track of budgetary expenditures and payments.
- Keep track and report (to Director-CPM) of regular progress of projects and compliance to site visit report timelines of all clinical studies and conduct regular trend-analysis of the report submissions.
- Facilitating tender notifications, procurement, storage and dispatch of investigational products.
- Providing oversight to project staff maintaining study master files to ensure their compliance with required regulatory and GCP quality standards and consistency with CDSA SOPs
- 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
1). 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.
2). Atleast 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
- Ability to develop and implement clinical research monitoring plans, SOPs, database concepts, and formats
- Understanding of GCP, regulations and 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 positon for a duration of Six months.
8. In case a 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 with a recent photo and cover letter indicating their motivation for the position applied for (150 words) and three references by e-mail with subject line mentioning “Application for the position “Project Manager” to cdsa_admin@thsti.res.in.
12. Incomplete applications will stand summarily rejected without assigning any reasons.
13. All results will be published on our website and all future communications will be only through email.
14. This position is based at CDSA Office, Faridabad located at NCR Biotech Science Cluster at Faridabad Gurgaon-Expressway, Faridabad.
15. Canvassing in any form will be a disqualification.
Applications will be accepted up to 4th September 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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