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. It works towards development of an eco-system for training and learning and work with public sector institutions, and small and medium enterprises (SME) to translate innovative technologies into medical products for public good.
Post : Quality Manager
Name of the Project : Effects of extreme heat on maternal, placental and fetal physiology, lactation and newborn health in India
Emoluments : Rs. 87,000/-
Age : up to 45 years
Essential qualifications and work experience :
• MBBS/BDS/BVSc. from a recognized university with four (4) years of demonstrated experience in clinical trial monitoring, clinical research, or clinical site management. OR
• Post-Graduation degree in Life Sciences/ Biomedical Sciences/ Pharmacy/ Public Health, from a recognized university with four (4) years of demonstrated experience in clinical trial monitoring, clinical research, or clinical site management. OR
• Bachelor’s degree in Life Sciences / Biomedical Sciences / Pharmacy/ Public Health from a recognized university with six (6) years of demonstrated experience in clinical trial monitoring, clinical research, or clinical site management The candidate must possess a valid GCP certificate.
Desirable - Two (2) years of work experience in Quality Control and Quality Assurance in clinical research.
Job profile
The Quality Manager (Clinical Monitoring & Oversight) 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.
b) All educational, professional and technical qualification should be from a recognized Board/University.
c) 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 the eligibility criteria.
d) Closing date of online application will be the CRUCIAL DATE for determining eligibility with regard to age, essential qualification, experience etc.
e) The age limit, qualification, experience and other requirements may be relaxed at the discretion of the competent authority, in case of candidates who are otherwise suitable.
f) 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 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 defence forces (Army, Navy & Air force) plus 3 years provided they have put in a minimum of 6 months attested service.
g) All results/notifications will only be published on our website. Therefore, the candidates should essentially visit THSTI website, regularly.
h) All communications will only be made through email.
i) In case a large number of applications are received, screening will be done to limit the number of candidates to those possessing higher/relevant qualification and experience.
j) The no. of vacancy indicated above may change subjected to the actual requirement at the time of Written test/skill test/interview.
k) With regard to any provisions not covered in this notification, the bye laws of THSTI / Govt. of India rules/ guidelines shall prevail.
l) Canvassing wrong information in any form will be a disqualification.
For posts mentioned above, interested candidates fulfilling the criteria as mentioned above may walk- in for written test/skill test/interview 16 September 2025 at 9:00 am on the date mentioned against each positions at THSTI, NCR Biotech Science Cluster, 3rd Milestone, Faridabad-Gurugram Expressway, Faridabad – 121001.
NOTE :
The candidates applying for the post mentioned on S. No. 1 must bring their latest resume, one set of photocopy of documents in support of their educational qualification and experience along with originals and a valid ID cards 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 will be mandatorily required to deposit their mobile phone along with a valid Identity proof at the reception and the same will only be returned back on completion of the entire selection process.
Date of walk-in interview : 10th March 2026 @09:00 AM at THSTI, NCR Biotech Science Cluster, 3rd Milestone, Faridabad-Gurugram Expressway, Faridabad – 121001
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