BRIC-Translational Health Science and Technology Institute (THSTI) is an Institute of the Biotechnology Research and Innovation Council, Department of Biotechnology, Ministry of Science & Technology, Govt. of India. The institute is an integral part of the interdisciplinary NCR Biotech Science Cluster located at Faridabad, with the mission to conduct innovative translational research and to develop research collaborations across disciplines and professions to translate concepts into products to improve human health.
Post : Project Manager (Monitoring)
This recruitment is to fill up the vacancies for project positions at Clinical Development Services Agency (CDSA) center. CDSA is a niche center of THSTI established to facilitate development of affordable healthcare products for public health diseases. It is the only public Centre in the country created with a mandate to support and nurture cost-effective, high quality, not-for-profit technology-based preclinical and clinical product development as well as support clinical research conducted by public agencies.
Number of the post : 01
Name of the Project : Efficacy. Safety, and Tolerability of Ayurveda regimen as an adjunct to anti- tuberculosis treatment (ATT) and macronutrient supplementation on body weight, nutritional outcomes, and quality of life in adults with newly diagnosed drug-sensitive NAAT-positive Pulmonary Tuberculosis: An open-label randomized controlled parallel-arm clinical study
Emoluments : Rs. 78,000/- + HRA
Age : Up to 45 years
Essential qualifications and work experience :
• Post Graduate Degree, including the integrated PG degrees, in any branch of Life Sciences with five (5) years’ post qualification experience in clinical trial monitoring. OR
• PhD in any branch of Life Sciences with two (2) years post qualification experience in clinical trial monitoring.
Desirable qualifications and work experience :
• Experience of clinical trial or public health project management in a recognised organisation/institute (academic clinical trials unit, CRO, pharmaceutical, biotechnology, or device company).
• Demonstrable experience of line management, project management concepts, and ability to understand, explain and communicate project concepts using standard tools and templates
The Project Manager (Monitoring) will be responsible for ensuring the quality, integrity, and compliance of assigned clinical research studies through robust monitoring and oversight activities. The role focuses on clinical site monitoring, quality assurance, risk-based oversight, and capacity building, while working in close coordination with the central study, regulatory, and project management.
Key Responsibilities :
Clinical Monitoring & Oversight
• Conduct site qualification, initiation, routine monitoring, and close-out visits for assigned clinical research studies in accordance with approved monitoring plans.
• Perform both onsite and remote monitoring to ensure subject safety, protocol adherence, data accuracy, and documentation completeness.
• Review source documents, CRFs, informed consent forms, and essential documents to ensure compliance with protocol, GCP, and applicable regulations.
• Identify, document, and follow up on protocol deviations, non-compliance issues, and data discrepancies.
• Ensure timely preparation and submission of monitoring visit reports and follow-up letters.
Quality Assurance & Compliance
• Support implementation and maintenance of quality management systems related to clinical monitoring and study oversight.
• Ensure adherence to ICH-GCP, Indian regulatory requirements, ethics committee approvals, and institutional SOPs during study conduct.
• Support audit and inspection readiness, including participation in audits
and follow-up on assigned Corrective and Preventive Actions (CAPAs).
• Contribute to the development and periodic review of monitoring plans, SOPs, checklists, and quality tools.
Risk-Based Monitoring
• Support the development and implementation of risk-based monitoring
strategies.
• Proactively identify study and site-level risks related to data quality, participant safety, or compliance.
• Escalate critical issues to the study leadership and Quality/CPM teams in a timely and documented manner. Training & Capacity
Building
• Deliver GCP, GDocP and monitoring-related training to site staff and study teams as required.
• Provide ongoing guidance and mentoring to site personnel to improve compliance, documentation quality, and operational performance.
• Serve as a trainer for clinical research and monitoring-related training initiatives conducted by CDSA, as assigned.
Coordination & Reporting
• Work closely with the central study team, data management team, and Quality/CPM leadership to ensure effective study oversight.
• Participate in internal study review meetings to provide updates on monitoring findings, site performance, and quality trends.
• Maintain accurate and inspection-ready documentation of all monitoring and quality oversight activities. Travel Requirement
• Must be willing to travel extensively to clinical sites across India, including short-notice travel and extended site visits when required.
Skills
• Strong understanding of clinical trial monitoring, GCP, and human subject protection.
• Demonstrated ability to independently manage assigned monitoring responsibilities with minimal supervision.
• Strong observational, analytical, and problem-solving skills.
• Excellent written and verbal communication skills in English.
• Ability to prepare clear and concise monitoring reports, quality summaries, and follow-up documentation.
• Proficient in MS Word, Excel, PowerPoint, and electronic clinical trial systems (EDC, CTMS, eTMF – as applicable).
• Professional judgment, integrity, and the ability to build trust with investigators and site teams.
• Ability to work collaboratively within multidisciplinary research teams.
General Terms & Conditions
a) These are the short-term positions, and extension will be granted subject to satisfactory performance of the incumbents and tenure of the project for which they are selected. Those appointed to these positions will not have any claim for regularization of their employment. All educational, professional and technical qualifications should be from a recognized Board/University.
b) The experience requirement specified above shall be the experience acquired after obtaining the minimum educational qualifications specified for the post. The candidates are required to satisfy themselves, before applying /appearing for the selection process, that they possess the minimum eligibility criteria as laid down in the recruitment advertisement. No query will be entertained with regard to eligibility criteria.
c) The date of Interview of the respective post will be the CRUCIAL DATE for determining eligibility with regard to age, experience, essential qualification etc.
d) Age and other relaxations for direct recruits and departmental candidates: 1. By five years for candidates belonging to SC/ST communities. 2. By three years for candidates belonging to OBC communities. 3. For Persons with Benchmark Disabilities (PwBD) falling under the following categories: (i) UR - ten years, ii) OBC - 13 years (iii) SC/ST - 15 4. Age is relaxable for Central Government servants up to five years in accordance with the instructions or orders issued by the Central Government, from time-to-time. 5. Institute/Department employees will get the age relaxation to the extent of the service rendered by them as on closing date of advertisement. 6. For Ex-servicemen upto the extent of service rendered in defense forces (Army, Navy & Air force) plus 3 years provided they have put in a minimum of 6 months attested service.
e) All results/notifications will only be published on our website. Therefore, the candidates should essentially visit THSTI website, regularly.
f) All communications will only be made through email.
g) In case many candidates appear for the walk-in interview, screening will be done to limit the number of candidates to those possessing higher/relevant qualification and experience.
h) The no. of vacancy indicated above may change subjected to the actual requirement at the time of Written test/skill test/interview.
i) With regard to any provisions not covered in this notification, the bye laws of THSTI / Govt. of India rules / guidelines shall prevail.
j) Canvassing wrong information in any form will be a disqualification.
Date of walk-in interview
28th October 2026 @09:00 AM at THSTI, NCR Biotech Science Cluster, 3rd Milestone, Faridabad-Gurugram Expressway, Faridabad – 121001
Note
1) The candidates must bring their latest CV/resume, one set of photocopy of documents in support of their educational qualification and experience, along with their originals and a valid ID card for verification.
2) Candidates coming after the time slot mentioned will not be entertained.
3) All the candidates coming for written test/skill test/interview at THSTI are mandatorily required to deposit their mobile phone along with valid Identity proof at the reception and the same will only be returned back on completion of the entire selection process.
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