lndian Council of Medical Research (ICMR) has initiated its flagship program by establishing an “lndian 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 accelerating the development of new diagnostics, new & improved vaccines and immunotherapies, drugs for TB.
Following post is to be filled purely on contractual basis for working under the programme entitled ‘lndia TB Research Consortium’ (ITRC) under Division of Epidemiology and Communicable Diseases (ECD), ICMR Hqrs Office, New Delhi.
Scientist C (Medical) (Medical Affairs and Clinical Development) - 01 post
Essential Qualification : Post Graduate Degree (MD/MS/DNB) after MBBS with one year experience OR Postgraduate diploma in medical subjects after MBBS with two years’ experience OR MBBS degree with 4 years’ in medical subjects after MBBS Degree.
Desirable Qualification and & Experience :
1. Master degree in the relevant subject (Community Medicine/ Preventive & Social Medicine/ Paediatrics/ Medicine/ Tropical Medicine/ Community Health Administration/Health Administration/ Family Medicine/ Epidemiology/ Public Health) from a recognized university.
2. Thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial conduct
3. Additional Post-doctoral research/teaching experience in relevant subjects in recognized institute(s).
4. Knowledge of Computer Applications or Business Intelligence tools /Data Management.
Nature of duties :
1. Co-ordinate the activities of the India TB Research Consortium
2. Ensure that all processes contributing to the performance of a clinical trial are conducted properly as per the ITRC SOPs and consolidate the information pertaining to all the projects and activities undertaken for finishing the assigned tasks on time.
3. Troubleshoot clinical trials and multi-centric projects.
4. Prepare and assist in preparing annual reports and quality trending reports.
5. Report the status of the quality levels of the staff, systems and production activities.
6. To organize meetings, take care of logistics and administrative and financial approvals, draft letters for sending to various organizations and prepare the draft minutes of the meeting.
7. Keep up to date with all quality and compliance issues.
8. Process matters for sanction of the projects as recommended by expert groups of ITRC, take follow-up actions till release of budget.
9. To review the progress reports of projects and take action for continuation
10. To work in team and undertake and share the responsibilities as and when required with other ITRC staff.
11. Initiate and Manage new/ongoing Vaccine/drug trial/clinical research/bio-medical research projects
12. Managing and maintaining databases for quality systems.
13. Preparation of the protocols and budget for studies.
14. Update the landscape documents in all thematic areas of TB.
15. Able to prepare SOPs for trial conduct.
16. Study feasibility, site feasibility, site identification (with CRPs) and site selection - Clinical studies and Observational Research
17. Regulatory submissions, in affiliates which are managed by Clinical Operations
18. Manage Site enrolment performance, and assist sites in recruitment planning
19. Develop site level risk plan for enrolment
20. The job may require travel to the trial sites and attending outstation meetings.
21. Any other job assigned by PI or Program Officer.
Age Limit : Upper age limit for fresh recruits 40 years
Emoluments : Rs. 64,000/- (corresponding to PB-3 Rs. 15,600 – 39,100 + Grade Pay Rs. 6,600) + HRA as applicable
Tenure : Upto 31st March 2021
Scientist C (Non - Medical) (Clinical Operations) - 01 post
Essential Qualification : Candidates should possess 1st Class Master Degree in Life Sciences or or 1st Class M. Pharm or any equivalent post from a recognized university with 4 years’ experience in CRO industry/Pharma/Biotech/ Public Health related to clinical research / trials
OR
2nd Class M. Sc. or 2nd Class M. Pharm or any equivalent post + PhD degree in relevant subjects from a recognized university with 4 years’ experience in experience in Pharma/Biotech/CRO industry/ Public Health related to clinical research / trials
Desirable Qualification and & Experience :
1. At least 2 year post Doc experience in biomedical subject particularly in health research related areas. Working experience in scholarly publications
2. Knowledge of computer applications or business intelligence tools/data management/data synthesis/Report writing, data mining, writing popular articles/working on databases.
3. Thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial conduct
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 CRO/vendors, 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
• To manage study files and process or administrative approvals
• Any other work assigned by the team leader pertaining to ITRC
• The job may require travel to the trial sites and attending outstation meetings
Age Limit : Upper age limit for fresh recruits 40 years
Emoluments : Rs. 51,000/- (corresponding to PB-3 Rs. 15,600 – 39,100 + Grade Pay Rs. 6,600)+ HRA as applicable
Tenure : Upto 31st March 2021
Scientist B (Non - Medical) (Coordinator) - 01 post
Essential Qualification :
Candidates should possess 1st Class Master Degree in Medical Pharmacology/Medical Microbiology/Clinical research or 1st Class M. Pharm or any equivalent post from recognized university with 2 years demonstrated experience in clinical trials/studies. OR OR
2nd Class Master’s Degree in Medical pharmacology/Medical Microbiology/Clinical research or 2nd class M.Pharm or any equivalent post with Ph.D. from a recognized University with 3 years demonstrated experience in clinical trials/studies.
Desirable Qualification and & Experience :
1. Additional research experience in communicable disease areas particularly TB, clinical trials and operational research.
2. Knowledge of Computer Applications or Business Intelligence tools /Data Management.
3. Thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial conduct
Job description:
1. Experience in conducting Vaccine/drug trial/clinical research/bio-medical research.
2. Experience in managing and maintaining databases for quality systems.
3. Knowledge of preparation of the protocol and budget for studies.
4. Update the landscape documents in all thematic areas of TB.
5. Able to prepare SOPs for trial conduct. 6. Thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial conduct
Nature of duties :
1. Co-ordinate the activities of the India TB Research Consortium
2. Ensure that all processes contributing to the performance of a clinical trial are conducted properly as per the ITRC SOPs and consolidate the information pertaining to all the projects and activities undertaken for finishing the assigned tasks on time.
3. To organize meetings, take care of logistics and administrative and financial approvals, draft letters for sending to various organizations and prepare the draft minutes of the meeting.
4. Coordination of project activities and Implementation at all sites. Communication to International and National agencies.
5. Preparation of financial documents, Data Programme Report, Report writing.
6. Manage all projects files with Divisional and process matters for sanction of the projects as recommended by expert groups of ITRC, take follow-up actions till release of budget.
7. Any other work that may be assigned from time to time by the concerned ICMR officials.
8. The job may require travel to the trial sites and attending outstation meetings
Age Limit : Upper age limit for fresh recruits 35 years
Emoluments : Rs 48,000/- (corresponding to PB – 3 Rs. 15,600 – 39,100 + Grade Pay Rs. 5,400) + HRA as applicable
Tenure : Upto 31st March 2021
Sr. Consultant (Scientific) (Medical/Non-Medical) - 01 post
Essential Qualification :
Professional with M.D. or Ph. D. (Medical Pharmacology/Medical Microbiology/Public health/Life Sciences) in relevant subject from recognized Institution and published papers with 20 years of experience in clinical research/clinical trial
OR
Retired Government employees with requisite educational qualification Ph.D in Life Sciences drawing pay in pay band of Rs.15,600/-39100+grade pay of Rs.6600/-at the time of retirement and having 20 years of experience in the research management/clinical trials special related to TB.
Desirable :
• Experience in successfully managing R&D programme in biomedical area
• Experience in clinical trials/ vaccine trial specially TB Vaccine trial
• Experience in development and execution of multicentric scientific programmes in biomedical area
Nature of duties :
• To provide vision and direction to the R&D programmes relating to Tuberculosis control by identification of alternate technologies/products/ interventions in the area of therapeutics, diagnostics and vaccines for taking forward the ITRC mandate.
• Ensure that all processes contributing to the performance of a clinical trial are conducted properly as per the ITRC SOPs and consolidate the information pertaining to all the projects and activities undertaken for finishing the assigned tasks on time
• To review and initiate the clinical studies undertaken by ITRC for validation of identified vaccine candidates; therapeutic agents; diagnostics and implementation research
• Oversee file management of the projects and their administrative approvals in time
• To provide effective coordination and management of the implementing sites/institutions identified for clinical studies/validation by ITRC.
• To promote innovation through public private partnerships, capacity building for management of Intellectual Property and technology transfer; organize industry-academic interface.
• Travel to study sites may be required for site visit
• Any task assigned by the Head/Programme Officer
Age Limit : Limited as on date: up to 70 years
Emoluments : Maximum Rs.1,50,000/- per month depending upon experience and knowledge
Tenure : Upto 31st March 2021
Consultant (Statistician/Senior Data Scientist) - 01 post
Essential Qualification :
Professional with M.D. (Community Medicine) or Ph.D (Statistics/Bio Statistics) from recognized Institution with 15 yrs. of experience in data management of Clinical trials and published papers
OR
Retired government employee with requisite educational qualification as above 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 data management of clinical trial/study.
Desirable :
• Experience of Data Management in multicentric clinical trials/studies specially drug trials/vaccine trials.
• Experience in handling clinical trial data-base
• Experience in data-cleaning, raising database queries, query resolution.
• Experience in handling and monitoring eCRF based studies
• Experience in statistical analysis and preparation of report
Nature of duties :
• To provide statistical support to all the studies/clinical trials Data management of all the clinical trials undertaken/coordinated by ITRC,ICMR
• Planning data analysis and overseeing data clinical management on site
• Preparation of Statistical Analysis Plan of various projects.
• Preparation of Clinical Study Report in consultation with implementing institutions.
• To provide statistical inputs on sample size calculation, data analysis etc. on development of protocols by ITRC.
• Any other related work assigned by the Head/programme officer
• f Data Management in multicentric clinical trials/studies specially drug trials/vaccine trials.
• Data-cleaning, raising database queries, query resolution.
• Monitoring data of eCRF based studies
• Statistical analysis of the studies and preparation of report
• Support in Manuscript writing
• The site visit may require travel outside Delhi
Age Limit : Limited as on date: up to 70 years
Emoluments : Upto Rs.100,000/- per month depending upon experience and knowledge
Tenure : Upto 31st March 2021
Terms and Conditions:
1. Departmental candidates or candidates working/have worked on projects of ICMR Institutes/Centre’s shall be given age relaxation to a minimum of five (5) years or a completed months/year based on earlier project service, whichever is less, they meet the essential qualification and experience prescribed for the post, with a view to provide them opportunity to compare with other candidates.
2. Age relaxation against post earmarked for reserved candidates will be as per Govt. of India Norms. No relaxation will be allowed in unreserved posts.
3. Qualification and experience should be in relevant discipline/field and from a reputed institution/organization recognized by relevant authority. Experience shall count from the date of completion of minimum educational qualification.
4. Submission of incorrect or false information daring the process of personal discussion and/or video conferencing shall disqualify the candidature at any stage.
5. Mere fulfilling the essential qualification / experience does not guarantee selection.
6. Candidates employed in Govt. Service / Semi Govt. Autonomous Bodies of State / Central Govt. should submit a ‘’No Objection Certificate’’ from their employer.
7. Above post is contractual for the duration offered may or may not be renewed subject to satisfactory performance and requirement.
8. Age will be reckoned from last date of receipt of application.
9. This post is purely temporary and co-terminable with the project. Employees will be on consolidated pay basis.
10. The appointment will be made on the basis of results of personal discussions and / or video conferencing mode.
11. Selected candidate will not have any right to claim for regular appointment in the council on the basis of contract appointment.
12. Candidates willing to apply for the post may download application from the ICMR website (main.icmr.gov.in). Duly filled application with Recent Photograph Along With Self-Attested Copies Of All Relevant Certificates And Experience Should Be Sent To ICMR New Delhi before 27/08/2020 by email at teamtbconsortium@gmail.com
13. Late received applications will not be considered. Only short-listed will be informed via Phone/email and called for interview/video-conferencing, no correspondence will be entertained in this regard.
14. Incomplete application, without photograph or without copies of relevant certificates will not be entertained. The Director ICMR reserves the right to increase/decrease the no. of posts or reject the applications or cancel the applications or cancel the notification without assigning any reason thereof.
15. No TA/DA will be paid for appearing in interview /video conferencing. Any canvassing by or on behalf of the candidates or to bring political or outside influence with regard to selection/recruitment shall be disqualification. 16. Shortlisted candidates will be called for personal discussion and / or video conferencing after verification of essential qualification and experience.
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. However, the selection Committee reserves the right to reduce the experience in case of deserving candidates.
Interested candidates for the position mentioned below are requested to send the updated Bio-Data with one photograph till 27th August, 2020 till 5.30 PM to the following address:
Head ECD II, Division of ECD, Indian Council of Medical Research,
V. Ramalingaswami Bhawan, Ansari Nagar, New Delhi, 110029.
The candidates can also send their CVs via email to teamtbconsortium@gmail.com; An interview would be held via webex/VC/ remotely on 31st August 2020 at 10.30 AM onwards. Eligible shortlisted candidates would be informed telephonically or via email (provided in CV) for the interview on the date mentioned.
Date and time of skype based interview
31st August 2020 10.30 AM onwards
(any change will be communicated via telephonically/email
Exact time will be communicated to the short-listed candidates by email or phone by 28/29 August 2020
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