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/-
Location : Gurugram Civil Hospital (GCH) and THSTI
Age : up to 45 years
Essential qualifications and work experience :
• MBBS, BDS, BVSc, BAMS, BHMS, BUMS, BSMS, BNYS, B.Sc. Nursing, BPT, B.Pharm from a recognized university with four (4) years of demonstrated experience in clinical trial monitoring or clinical site coordination & management experience. OR
• Graduation degree in Life Sciences/ Biomedical Sciences/ Public Health, from a recognized university with six (6) years of demonstrated experience in clinical trial monitoring or clinical site coordination & management experience. OR
• Post-Graduation degree or Ph.D. in Life Sciences/ Biomedical Sciences/ Pharmacy/ Public Health, from a recognized university with four (4) years of demonstrated experience in clinical trial monitoring or clinical site coordination & management experience. 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
• Oversees quality management processes and provides guidance and support to project teams to meet quality standards.
• Performs site monitoring throughout the trial, which involves visiting the trial sites regularly (from site initiation to site closeout) per the contracted scope of work.
• Actively lead or assist activities related to Internal Quality improvements and CAPA (Corrective and Preventive Actions).
• Ensure that the assigned study is conducted in accordance with study protocols, GCP guidelines, and applicable regulatory requirements.
• Lead or assist with identifying non-conformances with requirements, provide suitable recommendations, and facilitate ongoing quality improvements using a risk-based methodology.
• Proactively identify the project risks and assist in training study staff in good clinical and documentation practices.
• Maintain GCP-compliant processes that control the quality of work at the study sites.
• Complete appropriate therapeutic, protocol, and clinical research training to perform job duties.
• Setting up the trial sites such that each centre has the trial materials, including the trial supplies, while ensuring all trial supplies are accounted for in the study.
• Administers protocol and related trial training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.
• Conduct source document verification and case record forms for assessing the study trends.
• Management of essential documents for the duration of the trial at CDSA.
• Develop quality monitoring plan, SOPs, checklists and processes for clinical activities of data collection, laboratory-based activities of sample processing and storage, and running of the biorepository.
• Collaborate with clinical and project management teams to ensure compliance with quality standards, timelines, and appropriate follow-up in areas of deficiency.
• Coordinate expert monitoring visits/ audits as per project requirements.
• Willingness to frequently travel to all study sites.
• Work with the Clinical Portfolio Management department and other internal departments on their requirements as and when required.
• Work with data management and other key departments (laboratory, etc.) to track the process and progress and proactively ascertain the foreseen challenges.
Skills
• Good understanding of needs for projects and job responsibilities.
• Extensive knowledge of GCP/GLP, observational studies, and appropriate regulations and guidelines.
• Ability to develop and implement clinical and laboratory monitoring plans, SOPs, database concepts, and formats.
• Ability to build effective project teams, motivate others, delegate, drive, and make timely/ quality decisions.
• Operational skills including focus and commitment to quality management and problem solving.
• Influencing skills including negotiation and teamwork.
• Effective communication skills to provide timely and accurate information to all stakeholders.
• Ability to assess non-compliance situations, recognize the potential or actual broader strategic risk to the project and escalate when needed.
• Ability to identify systematic causes of complex quality problems and recommend long-term solutions.
• Create a fair and ethical culture that fosters high standards of ethics.
• Basic business computer skills (MS Word, Excel, e-mail).
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 :
1) The candidates applying for the above post 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.
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