Job Openings for Ph.D, M.Pharm as Consultant under Division of ECD at ICMR | Salary Rs 1 lakh pm
Indian Council of Medical Research (ICMR), New Delhi, the apex body in India for the formulation, coordination and promotion of biomedical research, is one of the oldest medical research bodies in the world.
The Govt, of India through Indian Council of Medical Research (ICMR) has initiated various projects for development of new tools and implementation strategies to support Govt, of India in achieving TB Elimination Goal by 2025.
Following posts are to be filled purely on contractual basis for working under the various projects under Division of Epidemiology and Communicable Diseases (ECD-I), ICMR Hqrs Office, New Delhi.
For TB Vaccine Trial
Consultant (Senior Protect Manager)
No. of post : One Post
Post Graduate Degree (MD/MS/DNB/Ph.D) after MBBS with four years of demonstrated core experience after postgraduation in Vaccine/drug trial from reputed Institution/CRO.
MBBS or equivalent with 8 years of demonstrated core experience in managing regulatory Vaccine/drug trial/ from reputed Institution/CRO.
1st class Masters degree M. Pharma/ or M.Sc in Pharmacology/ Biotechnology/life sciences with 8 years of demonstrated core experience in managing / monitoring regulatory Vaccine / drug trial from reputed Institution/CRO
• Experience in conducting Vaccine/drug trial/clinical research.
• Experience in establishing clinical trial sites, management &
implementation of trials and managing and maintaining databases for quality systems.
• Able to prepare & review SOPs and logs relevant requirement for trial sites
• Thorough knowledge of new clinical trial rules, Schedule Y, GCP, GCLP, ICH guidelines and regulatory requirements for conduct of clinical trial.
• Good communication skill
Age Limited as on date : up to 70 years
Nature of duties
• Establish and ensure that all processes for conduct of vaccine trials, CRFs, data management etc. are in place for ensuring expected performance.
• Prepare detailed project management plan and safety management plan and ensure execution as per plan.Prepare data management plan with data manager and ensure preparation of statistical analysis plan with help of statistician.
• Communicate with sites for ensuring smooth conduct and provide support as and when required.
• Co-ordinate with monitoring team for study compliance and study management/monitoring and obtain weekly updated reports from team.
• Submit updated site specific and consolidated progress report to Team leader/ Programme officer every week
• Troubleshoot with all sites for smooth conduct of vaccine trial.
• Prepare SAE management plan and Prepare and assist in preparing adverse event / serious adverse event narratives, safety reports, progress reports and quality trending reports.
• Will be responsible for site initiation and site management, monitoring timely reports of adverse event / serious adverse event by site Pis and communication with regulators.
• Report the status of the quality levels of the staff, systems and production activities.
• Keep upto date with all quality and compliance issues.
• Prepare interim and final Clinical report as per guidelines.
• Prepare relevant documents (note to files, protocol deviations etc.) and ensure timely submission to sponsor, IECs and Regulators.
• The job requires frequent All India travel to sites for monitoring, quality assurance and quality management.
• Ensuring operational approach of the vaccine trial are in place
• Any other duty assigned by the PI or Programme officer.
Consolidated Emoluments : Rs. 1,00,000/- per month depending upon experience and knowledge.
Tenure : Initial for one year and may continue upto three Years
Syllabus for written examination : Degree level related to project work, if Written Test conducted
Place of work : ICMR/DHR Hqrs., New Delhi
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