The Clinical Development Services Agency (CDSA) functions as an academic research unit established to facilitate the development of new drugs, treatment regimes, and affordable healthcare products. It aims to develop an ecosystem that supports the design, planning, and delivery of large-scale multi-centre clinical trials/cohort studies across a varied portfolio of clinical specialties. The unit works with public sector institutions and small and medium enterprises (SMEs) to translate innovative technologies and new drugs into medical products. CDSA was launched on 28 September 2009 as an extramural unit of Translational Health Science and Technology Institute (THSTI) by the Department of Biotechnology (DBT), Ministry of Science and Technology.
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.
This recruitment is to fill up the vacancies for project positions at Clinical Development Services Agency (CDSA) center.
Project Research Scientist – I (Medical)
No of post : One (01)
Name of the Project : Early Intervention with Low Molecular Weight Herparin (Enoxaparin) for Prevention of Moderate to Severe Acute Pancreatitis : A Double-Blind Placebo Controlled Investigator Initiated Multicenter Randomised Trial
Emoluments : Rs.67,000/- + HRA
Age: 40 years
Essential qualifications and work experience : MBBS, BDS, BVSc, BAMS, BHMS, BUMS, BSMS, BNYS, BPT, B.Pharm, Pharm.D or equivalent with two (2) years post-qualification experience in clinical project management and/or clinical trial/ study monitoring in a recognised organisation / institute (hospital, academic clinical trials unit, CRO, pharmaceutical, or medical device company)
The Project Research Scientist - I (Medical) is responsible for overseeing clinical trial sites from initiation to closeout, ensuring compliance with study protocols, ICH-GCP, applicable regulations, and internal SOPs. Responsibilities include :
• Conduct monitoring visits (on-site and remote), including initiation, routine monitoring, and closeout.
• Ensure trial sites comply with regulatory, protocol, and GCP requirements.
• Conduct risk-based monitoring and escalate site issues and protocol deviations appropriately.
• Verify informed consent and subject safety in alignment with ethical standards.
• Monitor AE/SAE reporting timelines to ensure compliance with regulatory requirements and escalate delayed submissions to the pharmacovigilance team.
• Review source documents and CRFs to verify data accuracy and consistency (SDV).
• Ensure appropriate management and documentation of investigational product (IP).
• Maintain essential trial documents in accordance with ICH GCP and local regulations.
• Prepare detailed monitoring visit reports and manage action items.
• Support regulatory and ethics submissions, patient recruitment, and resolution of data queries.
• Provide training to site personnel on study protocols, GCP, and SOPs.
• Ensure timely delivery and proper handling of study supplies and investigational product.
• Monitor quality metrics and assist with CAPA implementation.
• Ensure site readiness for audits and regulatory inspections.
• Use clinical trial systems (EDC, CTMS, eTMF) for tracking, documentation, and communication.
• Maintain effective communication with investigators and site staff to ensure study success.
• Frequently travel to assigned trial/study sites by eligible modes of travel.
• Work in collaboration with Clinical Portfolio Management on assigned projects, and provide support to other internal departments in fulfilling their requirements, as and when necessary.
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.
Note
1) The candidates applying for the 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.
Date of walk-in interview
12th January 2026 @09:00 AM
at THSTI, NCR Biotech Science Cluster,
3rd Milestone, Faridabad-Gurugram Expressway, Faridabad – 121001.
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