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 : CPM Assistant
Emoluments/ Duration : Up to 25,000 per month consolidated / 1 year
Location : CDSA Office, NCR Biocluster, Faridabad
Job profile
- Provide support to the CPM staff in administrative tasks, office operations and project tracking activities for efficient management of the SoW for new and sanctioned clinical studies or clinical programs.
- Provide the support for accurate forecasts for the project, procurement, planning, and tracking
- Implement and maintain effective administrative and project tracking systems / tools.
- Creation of administrative notes as per project requirements and tracking of approvals.
- Responsible for creation / providing inputs of clinical study documents for start-up activities including creation / shipment of Site Initiation Visit Kits and other study documents / dossiers as per project requirement.
- Supports creation, maintenance and period review of Trial Master Files, Tools and Systems for accuracy and completeness as per the regulatory and GCP requirements.
- Assist in collation and preparation of clinical study documents for submission for regulatory and EC approvals.
- Participate in CPM and Project Team meetings and assist in preparation of agendas, presentation materials, minutes, and tracking of action items.
- Liaise with Study Monitors / Team Leads, admin department and finance department for arrangements of monitoring visits, conferences, workshops etc.
- Coordinate with cross-functional departments for travel and accommodation arrangements for delegates of project meetings, investigator meetings etc.
- Assist project teams in vendor payments and maintain tracking of payments.
- Support respective team leads for updation in CTMS and study tracking tools
- Assist project team in the preparation, handling, distribution, filing, and archiving of clinical study documentation as per departmental SOPs and project requirements.
- Work with Clinical Portfolio Management and other internal departments on their requirements as and when required
Eligibility
1) Graduate a 2-3 years’ experience or Post graduate with an year’s experience of handling administrative work
2) Candidate with clinical research experience with a recognized institute / organization will be preferred
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Skills
Strong communication skills both verbal and written in English.
Proficient in Microsoft Office, including Word, Excel, PowerPoint, Outlook etc. and working experience with project management software
Ability to work under pressure, exhibit integrity in behavior and action.
Ability to remain flexible and work independently with minimal guidance as well as collaboratively within a team setting.
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 position 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 “CPM - Assistant” 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.
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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