The 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 Primary objective of Tata Trusts is to impact the quality of life of the community. Tata Trusts have been working on a range of thematic areas cutting across diverse developmental issues like Health, Education, Media & Arts, Natural Resources & Livelihoods and Urban Poverty
The Govt. of India through Indian Council of Medical Research (ICMR) has proposed to setup an “Indian TB Research Consortium” to advance technology and product development by harnessing interdisciplinary expertise and regional complementary strengths and focus on building and strengthening scientific capabilities and generating a better understanding to aid in accelerating the development of new diagnostics, new & improved vaccines and Immunotherapies, drugs for TB.
ICMR & Tata Trusts have an MOU wherein Tata Trusts have provided initially provide support for establishing interim Secretariat, hiring of Consultants (Scientific and Administrative) and for various activities
Following posts are to be filled purely on temporary basis for working at ICMR Hqrs Office, New Delhi for ‘India TB Research Consortium (ITRC)’ in collaboration with Tata Trusts and related activities initially for a period of one year.
1 & 2. Consultants(Scientific) - Three
1. Consultant ( Scientific): Medical writer (Clinical Development) (2)
2. Consultant ( Scientific): Clinical Operations(1)
Consultant (Scientific): Clinical Development
Salary*: Rs. 60000/ to Rs. 100000/ (consolidated) per month (negotiable depending on qualifications)
Qualification: Consultant (Scientific): Clinical Development 1st Class Master’s Degree in Life Sciences from a recognized University with Ph.D. in relevant subject (Life Sciences pertaining to infectious diseases) from a recognized University with 2 - 5 years’ experience in Pharma/ Biotech/ CRO Industry/ Public Health OR 1st Class Master’s Degree in Life Sciences from a recognized University with Degree/Diploma in clinical Research with 2 -5 years’ experience in Pharma/ Biotech/ CRO Industry/ Public HealthOR M.B.B.S & MD with 2-5 experience in Pharma/ Biotech / CRO Industry OR related field of infectious diseases after MD or MBBS with eight years’ experience in related in Pharma/ Biotech / CRO Industry/ Public Health
Desirable Qualification
i. Experience in biomedical research preferably in TB or other infectious diseases
ii. Good Scientific writing/Communication skills.
iii. Knowledge of computer applications or business intelligence tools/ data management / data synthesis
iv. Knowledge of GCP, ICH guidelines and regulatory requirements for product development (Drugs/ vaccines/ Diagnostics).
Job Responsibilities
• To work under team leader and complete the specialized tasks assigned in the related area of work and would be responsible for finishing the assigned tasks on time.
• Literature review for the study molecule so as to draft study protocols for Phase I/ II/ III clinical trials for Drugs and Vaccines and related area of research
• Discussing, obtaining and incorporating inputs from the Manufacturer, Pharmacokinetic, analytical, statistical, Quality assurance department, Principal Investigator, Clinical investigators and Project Mangers into the study protocol
• Organizing and co-coordinating protocol review meets whenever required by ITDRC
• Preparation of the Informed Consent Documents , Investigator’s Brochure and other study related documents as per ICH/ GCP and WHO guidelines
• Supporting Clinical data management for design of CRF, follow up for inputs and finalization.
• Preparing amendment for protocol and related documents
• Coordinating with Regulatory team for regulatory filing of dossiers and making study protocol presentation to DCGI office
• Travel to trial sites for assessment and monitoring
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Consultant (Scientific): Clinical Operations
Qualification: 1st Class Master’s Degree in Life Sciences from a recognized University in relevant subject (Life Sciences pertaining to infectious diseases) from a recognized University with 4 - 7 years’ experience in Pharma/ Biotech/ CRO Industry/ Public Health OR 1st Class Master’s Degree in Life Sciences from a recognized University with Ph.D. in relevant subject (Life Sciences pertaining to infectious diseases) from a recognized University with 2 - 5 years’ experience in Pharma/ Biotech/ CRO Industry/ Public Health OR 1st Class Master’s Degree in Life Sciences from a recognized University with Degree/Diploma in clinical Research with 2 -5 years’ experience in Pharma/ Biotech/ CRO Industry/ Public Health OR M.B.B.S & MD with 2-5 experience in Pharma/ Biotech / CRO Industry OR related field of infectious diseases after MD or MBBS with eight years’ experience in related in Pharma/ Biotech / CRO Industry/ Public Health
Desirable Qualification
• Experience in managing multicenteric clinical trials of drugs and vaccines for regulatory submission
• Able to prepare Standard Operating Procedures for Trial conduct
• Knowledge of GCP, ICH guidelines and regulatory requirements for clinical trials conduct
Job Responsibilities:
• To work under team leader and complete the specialized tasks assigned in the related area of work and would be responsible for finishing the assigned tasks on time.
• To co-ordinate and assist the Program Director.
• To take care of documentation part like MoUs, landscape documents, etc
. • To Manage all clinical aspects of study including: assesses operational feasibility and recommends study execution plan; develops and manages comprehensive study timelines and metrics
• To participate in selection and management/oversight of external vendors and develops vendor specifications; reviews vendor reports, budgets, and metrics
• To provide study-specific training and leadership to clinical research staff, including CRO, CRAs, sites and other contract personnel
• To plan, execute, and lead study-specific meetings (e.g., Study Management Meetings, investigator meetings, Advisory Committee)
• To participate in site monitoring visits as appropriate and oversee clinical monitoring activities ensuring compliance with Good Clinical Practices (GCP) and applicable regulations.
• To prepare and/or reviews study-related Standard Operating Procedures and documents
• To select sites and develop relationships with investigators and site staff.
• To develop and manage study budget and maintains it within financial goals
• To ensure all clinical trials are executed in compliance with international GCP guidelines/regulations and SOPs:
• To participates in the selection, training, and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function.
Age Limit: Not exceeding 50 years.
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Consultants Coordinator – One (Scientific)
Salary*: Rs. Rs.50000/ - 60,000/ (consolidated) per month (negotiable depending on qualifications)
Qualification: 1st Class Master’s Degree in Life Sciences from a recognized University with twoyearsexperience in relevant field of infectious diseases of which one year should be in TB research
Desirable Qualification: i. At least oneyear R&D / Industry experience in infectious disease areas or two years Experience in biomedical research preferablyin TB withGood Scientific writing/Communication skills. ii. Knowledge of computer applications or business intelligence tools/ data management / data synthesis.
Job Responsibilities:
• Communication to International and National agencies.
• Preparation of financial documents, EFC, Cabinet Note, Data Programme Report.
• Drafting letters for sending to various organizations
• Assisting Consultant Scientific
• Obtain approvals on files.
• Report writing.
• To work under Consultant Scientific and complete the specialized tasks assigned in the related area of work and would be responsible for finishing the assigned tasks on time.
• Any other work that may be assigned from time to time by the Program Director and the Consultant Scientific
Age Limit: Not exceeding 50 years.
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Consultant (Accounts cum Admin): One
Salary*: Rs.60000/ - Rs.70,000/ (consolidated) per month. (negotiable depending on qualifications)
Qualifications:
Bachelor’s Degree in Commerce from a recognized University with sound knowledge of Accountancy and GFR and 5 years experience of Accounting Management from a reputed Institution/Project.
Desirable: Proficiency in the latest Accounting packages and Knowledge of MS Office (Word, Power Point, Excel) alongwith latest version of Tally. Age: Not exceeding 45 years
Job Responsibilities
• Responsible for all administrative work
• Maintaining log files
• Maintaining accurate records of expenditure incurred in the project.
• Disbursement of salaries to the staff and maintain accounts
• Systematic Accounting of Funds received for the project
• Ensure timeliness in completing the tasks assigned
• Preparing budget estimates
• Preparation of Annual Reports of Income & Expenditure
• Any other work that may be assigned from time to time by the Management
Interested candidates may apply by submitting their resume along with the detailed information as per the requirements given below on or before 25-05-2017 to teamtbconsortium@gmail.com or drmanjulasb@gmail.com . It may be noted that only the short-listed candidates will be called for interview. The date and time of the Interview will be informed through e-mail/phone/and will also be displayed on ICMR website.
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