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 Govt. of India through Indian Council of Medical Research (ICMR) has initiated its flagship program by establishing 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.
Following posts are to be filled purely on contractual basis for working under the Division of Epidemiology and Communicable Diseases (ECD)-I ICMR Hqrs Office, New Delhi for program on India TB Research Consortium (ITRC).
Consultant (Scientific) Biomedical Research Quality Assurance - 01 post
Essential Qualification
Post Graduate Degree (MD/MS/DNB) after MBBS with one year clinical experience OR Postgraduate diploma after MBBS with 2 years clinical experience with the recognised government institution OR MBBS with four year clinical experience in Government Institution OR 1st class Masters in Medical Pharmacology/Medical Microbiology with 4-6 years experience in clinical trials/studies.
Desirable
• Experience in evaluating quality events, incidents, queries and complaints and handling compliance issues.
• Experience in managing and maintaining databases for quality systems.
• Able to prepare SOPs for trial conduct.
• Thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial conduct.
Age
Limited as on date: up to 70 years
Nature of Duties
• Ensure that all processes contributing to the performance of a clinical trial are conducted properly.
• Troubleshoot clinical trials and activities.
• Prepare and assist in preparing annual reports and quality trending reports.
• Report the status of the quality levels of the staff, systems and production activities.
• Preside over improvement programmes.
• Keep upto date with all quality and compliance issues.
Consolidated Emoluments : Maximum Rs.70,000/- per month depending upon experience and knowledge.
Tenure : Two Years
Syllabus for Written Examination : Degree level related to project work, if written Test conducted
Place of Work : ICMR Hqrs.
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Consultant (Clinical Coordinator) (Medical) - 01 post
Essential Qualification
Post graduate Degree (MD/MS/DNB) after MBBS with 1 year experience OR Post graduate Diploma in Medical subject after MBBS with 2 year experience OR MBBS with 4 year clinical/research experience in Govt. Institution. OR Ist class Masters in Medical Pharmacology/Medical Microbiology with 4-6 years experience in clinical trials/studies.
Desirable
• Able to prepare SOPs for trial conduct.
• Thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial conduct.
• Experience in co-ordinating project activities
• Good communication skills
Age
Limited as on date: up to 70 years
Nature of Duties
• Coordination of project activities and Implementation at all sites.
• Communication to International and National agencies.
• Preparation of financial documents, Data Programme Report, Report writing.
• Drafting letters for sending to various organizations.
• Any other work that may be assigned from time to time by the concerned ICMR officials.
• The job may require travel to the trial sites and attending outstation meetings.
Consolidated Emoluments : Maximum Rs.70,000/- per month depending upon experience and knowledge.
Tenure : Two Years
Syllabus for Written Examination : Degree level related to project work, if written Test conducted
Place of Work : ICMR Hqrs.
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Consultant (Scientific) Clinical Development - 01 post
Essential Qualification
Post Graduate Degree (MD/MS/DNB) after MBBS with one year clinical experience OR Postgraduate diploma after MBBS with 2 years clinical experience with the recognised government institution OR MBBS with four year clinical experience in Government Institution OR Ist class Masters in Medical Pharmacology/Public health from a recognized University with 4 years of experience in Pharma industry/CRO industry/Bio-tech industry /Public Health
Desirable
• PhD in relevant subject from a recognized University
• Experience in biomedical research preferably in TB or other infectious disease
• Good scientific writing/Communication skills.
• Knowledge of computer applications or business intelligence tools management/ data synthesis.
Age
Limited as on date: up to 70 years
Nature of Duties
• Study feasibility, site feasibility, site identification (with CRPs) and site selection - Clinical studies and Observational Research
• Deliver all regional, local, and corporate portfolio commitments/milestones for sites and trials within responsibility
• Support local needs of globally outsourced studies within responsibility
• Manage IITs
• Regulatory submissions, in affiliates which are managed by Clinical Operations
• Manage the allocation of patients within the geography
• Manage Site enrolment performance
• Assist sites in recruitment planning
• Develop site level risk plan for enrolment
• Primary interface with investigators
• Manage the link between site and the TPO
• Collaborate with partners and other study team members to resolve/escalate site specific issues when necessary
• Contribute to and partner with the local medical organization to deliver on department goals .
• The job may require travel to the trial sites and attending outstation meetings
Consolidated Emoluments : Maximum Rs.70,000/- per month depending upon experience and knowledge.
Tenure : Two Years
Syllabus for Written Examination : Degree level related to project work, if written Test conducted
Place of Work : ICMR Hqrs.
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Consultant (Scientific) Clinical Operations - 01 post
Essential Qualification
Post Graduate Degree (MD/MS/DNB) after MBBS with one year clinical experience OR Postgraduate diploma after MBBS with 2 years clinical experience with the recognised government institution OR MBBS with four year clinical experience in Government Institution OR 1st Class Master’s Degree in Medical Pharmacology/ Public Health from a recognized University with 4-6 years of experience in Pharma/Biotech/CRO industry/ Public Health related to clinical research / trails.
Desirable
• PhD in Microbiology, Pharmacology/ Public Health from a recognized University
• Experience in managing clinical trials of drugs and vaccines for regulatory submission
• Able to prepare standard operating Procedures for the trial conduct.
• Knowledge of GCP, ICH guidelines and regulatory requirements for clinical trials conduct.
Age
Limited as on date: up to 70 years
Nature of Duties
• To manage all clinical aspects of study including assessing operational feasibility and recommending study execution plan; developing and managing comprehensive study timelines and metrics
• To participate in Selection and management/Oversight of external vendors and develops vendor specifications; review 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
• To participate in Site monitoring visits and oversee clinical monitoring activities ensuring compliance with Good Clinical Practices
• To prepare and/or review study related Standard Operating procedures and Documents
• To develop and manage study budget and maintain it within financial goals
• Any other work assigned by the team leader pertaining to ITRC
• The job may require travel to the trial sites and attending outstation meetings
Consolidated Emoluments : Maximum Rs.70,000/- per month depending upon experience and knowledge.
Tenure : Two Years
Syllabus for Written Examination : Degree level related to project work, if written Test conducted
Place of Work : ICMR Hqrs.
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Consultant (Scientific) Pre-Clinical operations - 01 post
Essential Qualification
Post Graduate Degree (MD/MS/DNB) after MBBS with one year clinical experience OR Postgraduate diploma after MBBS with 2 years clinical experience with the recognised government institution OR MBBS with four year clinical experience in Government Institution. OR 1st Class Master’s Degree in Medical Microbiology/ Medical Pharmacology/Immunology from a recognized University with 4-6 years of experience in Pharma industry/Biotech industry /CRO industry / Immunology related to clinical research studies / trials.
Desirable
• PhD in Medical pharmacology/medical microbiology/immunology from a recognized University
• Strong knowledge of clinical research process and medical terminology.
• Understanding of GCP/ICH guidelines.
• Knowledge of regulatory requirements and guidelines governing clinical research.
• Ability to work successfully within a cross- functional team
• Good Scientific writing/Communication skills Knowledge of computer applications or business intelligence tools/data management / data synthesis
Age
Limited as on date: up to 70 years
Nature of Duties
• To manage all clinical aspects of study including assessing operational feasibility and recommending study execution plan; developing and managing comprehensive study timelines and metrics
• To participate in Selection and management/Oversight of external vendors and develops vendor specifications; review 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
• To participate in Site monitoring visits and oversee clinical monitoring activities ensuring compliance with Good Clinical Practices
• To prepare and/or review study related Standard Operating procedures and Documents
• To develop and manage study budget and maintain it within financial goals
• The job may require travel to the trial sites and attending outstation meetings
Consolidated Emoluments : Maximum Rs.70,000/- per month depending upon experience and knowledge.
Tenure : Two Years
Syllabus for Written Examination : Degree level related to project work, if written Test conducted
Place of Work : ICMR Hqrs.
Interested candidates for the various positions mentioned below are invited to appear for the Walk-in-Written Test/ Interview as mentioned for the various positions along with 5 copies of their updated Bio data/CV on the respective dates indicated against the notified positions reporting strictly between 09:00 A.M to 10:00 A.M at the following address :
Reception hall,
Indian Council of Medical Research,
Ramalingaswami Bhawan, Ansari Nagar New Delhi-110 029
Date & Time of Written Test/ Interview :24rd February,2018 strictly between 09:00 A.M to 10:00 A.M
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