Work as CPM Assistant at Clinical Development Services Agency
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
- 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
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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