Applications are invited from eligible candidates for the following post (purely contractual) on consolidated salary for working under Flagship programme ‘India TB Research Consortium’(ITRC) under Division of Epidemiology and Communicable Diseases (ECD-I), ICMR Hqrs Office, New Delhi.
For India TB Research Consortium
Sr. Consultant (Scientific)
Essential Qualification & Minimum Experience required
MBBS with M.D. (Pharmacology/Medicine/Medical Microbiology/Public health) in relevant subject from recognized Institution having 15 years of demonstrated experience in the research managemcnt/clinical trials and published papers.
OR
Retired Government employees with requisite educational qualification drawing pay in pay band of Rs.15,600/-39100+grade pay of Rs.6600/-at the time of retirement and having 15 years of experience in the research managcment/clinical trials and Published papers.
Desirable
• Experience in successfully managing R&D programme and clinical studies/trials in biomedical research.
• Experience in development and execution of multicentric scientific programmes in biomedical area
Age Limited as on date : up to 65 years
Nature of Duties
• To provide managerial insight to the R&D programmes relating to Tuberculosis control by timely execution of all activities as per the work as per the defined SOPs and scope of work of the Programme.
• Provide expertize to various activities like the detailed landscape analysis of research leads, identification of alternate technologies/products/interventions in the area ol therapeutics, diagnostics and vaccines tor taking rorwaru as pei me mxv. mandate.
• To provide support in development of the clinical studies to be undertaken by ITRC for validation of identified vaccine candidates; therapeutic agents; diagnostics and implementation research and monitor progress for timely completion
• To provide effective coordination and management to the implementing sites/institutions identified for clinical studies/validation by ITRC.
• To provide support in development of periodic progress report of the programme.
• To promote innovation through public private partnerships, capacity building for management of Intellectual Property and technology transfer; organize industry-academic interface.
• To supervise administrative and finance related work for various approvals, submission of documents for smooth functioning of ITRC.
• Any other task assigned by team lead, Head of the Divison
• Travel to study sites for meetings/site monitoring
Consolidated Emoluments : Maximum Rs. 1,50,000/- per month consolidated depending upon experience and knowledge .
Tenure : Initially 6 months; may be extended as per project period
Place of Work : ICMR Hqrs
For Project Management Unit for ‘TB Vaccine trial’ under ITRC
Consultant (Senior Proiect Manager)
Essential Qualification & Minimum Experience required
Post Graduate Degree (MD/MS/DNB/Ph.D) after MBBS with lour years ot demonstrated core experience after postgraduation in Vaccine/drug trial trom reputed Institution/CRO. OR
MBBS or equivalent with 8 years of demonstrated core experience in managing regulatory Vaccine/drug trial/ from reputed Institution/CRO.
OR
1st class Masters degree M.Pharma/ or M.Sc in Pharmacology/ Biotechnology/life sciences with 10 years of demonstrated core experience in managing / monitoring regulatory Vaccine / drug trial from repute Institution/CRO
Desirable
• Experience in conducting Vaccine/drug trial/clinical research.
• Experience in establishing clinical trial sites, management & implementation of trials and managing and maintaining databases lor 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 60 years
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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 1 earn 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, lECs 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 : Maximum Rs. 1,00,000/- per month consolidated depending upon experience and knowledge.
Tenure : Initial for one year and may be extended upto project period
Place of Work : ICMR Hqrs, New Delhi
Selection Procedure: Only shortlisted candidates would be notified via e-mail or telephone. The Interview will be conducted for the shortlisted candidates. However, if more number of candidates are shortlisted for the post advertised, Written Test/ Skill Test may also be conducted on the same day before final round of Interview.
GENERAL CONDITIONS: The conditions of employment will be the same as that of the project staff on contract basis. The candidates have no right to claim for any regular employment at this Institute. The appointing authority has the right to accept/ reject any application without assigning any reason(s) and no correspondence in this matter will be entertained. Age, Qualification, experience etc., will be reckoned as on the date ol walk-in-written test/ Interview.
Eligible and interested candidates may send their applications in the attached proforma via e-mail at recruitments.teamtbconsortium@gmail.com till 20th September, 2019 or submit their hard copies at Room No. 303, Division of Epidemiology and Communicable Diseases, V Ramalingaswami Bhawan, Ansari Nagar, New Delhi clearly mentioning the name of the post. (However, an e-mail application may also be submitted) till 20th September, 2019.
Late applications will not be accepted under any circumstances.
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