Ph.D, M.Pharm, MSc recruitment under various TB projects

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 accelerating the development of new diagnostics, new & improved vaccines and immunotherapies, drugs for TB.

For India TB Research Consortium

Consultant (Statistician/Senior Data Scientist)
No. of Vacancies : One Post
Essential Qualification& Minimum Experience required :
Professional with M.D. (Community Medicine) or Ph. D (Statistics/Bio Statistics) or M. Tech /Ph.D (Computer science) 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 and 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
Age : Limited as on date: up to 70 years
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
• 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
Consolidated Emoluments : Upto Rs.100,000/- per month depending upon experience and knowledge
Tenure Upto : 31/03/2021
Place of Work : ICMR Hqrs.

For Project Management Unit for ‘TB Vaccine trial’

Scientist C (Medical) (Clinical Services) - Two
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 clinical research/trial after MBBS Degree
Desirable Qualification and & Experience:
1. Experience in conducting Vaccine/drug trial/clinical research /Clinical Management.
2. Able to prepare safety reports and ensure the timely management and reporting of AEs an SAEs by sites by supporting them
3. Experience in managing and maintaining databases for quality systems.
4. Able to prepare SOPs for trial conduct and write safety reports and SAE narratives.
5. Thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial conduct.
6. Good communication skills
Nature of duties:
• Monitor the clinical trial and Prepare strategy for site monitoring and timely completion of recruitment targets and follow -up visits
• Checking of resources and Site initiation
• Monitor vaccine trial, check all the source documents and completeness of data CRFs and ensuring timely completion of data entry in compliance with study protocol.
• Review SAE tracker and SAE document repository every 15 days
• Prepare a patient tracker and discuss with site PI to ensure compliance and minimize missing visits of subjects
• To match the tracker every week against recruitment target for each site and take necessary actions accordingly
• Discussion with PI’s and project staff for patient compliance
• Review of Ensure that all processes contributing to the performance of a clinical trial are conducted properly.
• Prepare and assist in preparing annual reports and quality trending reports.
• Prepare the site wise and consolidated site report regarding enrollment data vs. targets and share with Team lead/PO every week.
• Keep upto date with all quality and compliance issues and Report the status of the quality levels of the staff, systems and production activities.
• Any other job assigned by the PI or Programme officer
• Job requires frequent All India travel to sites for monitoring, quality assurance and quality management for at least 15 days a month.
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 : One year (Extendable upto 2 years after review)

Scientist C (Non - Medical) (Project Manager) - One
Essential Qualification: Candidates should possess 1st Class Master’s Degree in Life Sciences or 1st Class M. Pharm or any equivalent degree from a recognized university, 4 years of core experience in managing/monitoring of regulatory clinical trials specially Vaccine/drug trial from reputed Institutions OR 2nd Class M.Sc. or 2nd Class M. Pharm or any equivalent degree with Ph.D degree in relevant subjects from a recognized university,4 years of core experience post Ph.D in managing/monitoring of regulatory clinical trials specially Vaccine/drug trial from reputed Institutions.
Desirable Qualification and & Experience:
• Experience in conducting/managing and monitoring regulatory clinical research/ trials and carry out all the activities related to regulatory trials
• Experience in checking all source documents and cross check data entry in CRFs.
• Experience in managing and maintaining databases for quality systems.
• Able to prepare SOPs, logs etc. for trial conduct.
• Thorough knowledge of New clinical trial guidelines, Schedule Y, GCP, GCLP, ICH guidelines and regulatory requirements for clinical trial conduct. Good communication skills
Nature of duties:
• Able to execute the project monitoring plan for a regulatory preventive vaccine clinical trial.
• Prepare for Site initiation and Monitor vaccine trial, check all the source documents and entry of data in CRFs and ensuring timely completion of data entry and compliance with study protocol and completion of recruitment target.
• Ensure that all processes contributing to the performance of a clinical trial are conducted properly.
• Should be able to provide Training on study procedures, safety reporting, GCP, regulations & GDP and Dry run of activities
• Troubleshoot processes for smooth conduct of multicentric regulatory vaccine trials.
• Prepare study progress reports and quality trending reports.
• Report the status of the quality levels of the staff, systems and activities and should be able to provide training in project conduct related activities of the vaccine trial.
• Keep upto date with all quality and compliance processes and issues.
• Any other job assigned by the PI or Programme officer
• The job may require frequent All India travel to sites for project management and monitoring, quality assurance and quality management and should be able to travel at least 15 days a month for study monitoring
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 : Initial for one and may continue upto two Years based on review

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 must 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. Late received applications will not be considered. Only short-listed candidates will be informed via Phone/email and called for interview/video-conferencing, no correspondence will be entertained in this regard.
13. 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.
14. 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.
15. Shortlisted candidates will be called for personal discussion and / or video conferencing after verification of essential qualification and experience.

Following post is to be filled purely on contractual basis for working under various TB projects under Division of Epidemiology and Communicable Diseases (ECD), ICMR Hqrs Office, New Delhi. Interested candidates for the position mentioned below are requested to send the updated Bio-Data with one photograph up to 09:00AM till 14thOct. 2020 through the given link. The link will become Late received applications will not be entrained. The applications will be screened on the same day from 09:00 AM onwards. Web-Link to join the interview will be shared with eligible candidates about 30 minutes before the interview.

How to apply:
i. Candidates should apply online.
ii. Following self attested required documents are to be enclosed with the application:- a) Proof of Date of Birth, b) Educational qualifications, c) Experience as per essential criteria, d) Relevant document if seeking for relaxation of age.
iii. Application should be submitted online.
iv. Candidate should state the name of the project and post applied for.