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.
This recruitment is to fill up the vacancies of BRIC-THSTI under the following projects
Clinical Project Manager
No of post : 01
Name of the Project : Sepsis-related mortality in neonates in India: A multi-disciplinary, multi- institutional research program for context -specific solutions
Emoluments : Rs. 78,000/- + HRA
Age : Up to 45 years
Essential qualifications and work experience :
• MBBS/BDS/BVSc with a minimum of five (5) years of experience in clinical project management and/or clinical trial/ study monitoring. OR
• Master’s Degree or PG Diploma or PhD in Life Sciences / Biomedical Sciences / Pharmacy / Public Health / Clinical Research with at least five (5) years of experience in clinical project management and/or clinical trial/ study monitoring. AND
• Experience in clinical trial or public health project management in a recognised organisation/institute (academic clinical trials unit, CRO, pharmaceutical, biotechnology, or medical device company) Desirable qualifications and work experience :
• Postgraduate degree in Public Health
• MD/DNB from a recognised Indian University/recognised by MCI
• PhD in a health-related discipline
• Demonstrable experience of line management, project management concepts, and ability to understand, explain and communicate
• Project management concepts using standard tools and templates.
Job profile
The Clinical Project Manager is responsible for overseeing, managing, and executing the operational aspects of assigned clinical studies and trials, ensuring the timely delivery of milestones while upholding the highest standards of quality, compliance, and scientific integrity. The role demands cross-functional leadership, operational excellence, and a strategic mindset to support complex clinical research programs.
Key Responsibilities :
• Maintain the integrity of clinical trials by monitoring data, processes, and documentation through both onsite visits and remote oversight.
• Conduct site qualification, initiation, monitoring, and close-out visits for assigned clinical trials/research studies. Must be willing to travel to clinical sites across India on short notice and stay for extended durations as needed.
• Lead cross-functional coordination efforts, working closely to develop, implement, and maintain comprehensive project plans and timelines. Clearly communicate project expectations to all relevant team members and consultants. • Manage overall project budgets to ensure alignment with scope and financial objectives.
• Support the implementation and maintenance of systems related to resource planning, study administration, monitoring, quality assurance, and documentation, under the supervision of the Chief - Clinical Portfolio Management (CPM).
• Undertake additional responsibilities within the Clinical Portfolio Management team as required by project deliverables or organisational needs.
• Establish and enforce procedures to ensure adherence to study protocols, regulatory requirements, and organizational standards.
• Ensure adherence to applicable regulatory and ethical frameworks, including oversight by regulatory authorities, ethics committees, and other governing bodies.
• Coordinate and support audit readiness and audit processes, including the development of Corrective and Preventive Actions (CAPAs).
• Liaise with the Steering Committee and Data Safety Monitoring Board (DSMB) to ensure compliance with Research Governance, Good Clinical Practice (GCP), Data Protection, and Ethical Guidelines.
• Prepare or oversee regulatory and ethics submissions, amendments, and responses to regulatory queries, ensuring timely approvals and renewals.
• Develop and deliver project-specific and protocol-specific training, as well as additional training as requested.
• Provide ongoing guidance, mentorship, and operational training to project staff as needed.
• Serve as trainer for training initiatives conducted by CDSA.
• Collaborate with Investigators to monitor study progress, ensure meaningful outputs, and support necessary protocol or funding amendments based on study findings or operational needs.
• Facilitate partnerships with sponsors, collaborators, and regulatory bodies to support compliance, reporting, and trial visibility.
• Engage external stakeholders such as funding bodies and governmental agencies to enhance trial impact and reach.
• Oversee the development, approval, and distribution of essential study documents, including study protocols, Case Report Forms (CRFs), study manuals, and tools for investigational sites and review boards.
• Manage regulatory documentation workflows, including distribution, collection, and tracking, ensuring compliance and audit readiness.
• Collaborate with data management and other departments to monitor project milestones, assess challenges, and drive progress.
• Evaluate, implement, and oversee clinical trial management systems (CTMS), electronic data capture (EDC), and eTMF systems.
• Act as the point of contact for clinical systems integration, troubleshooting, and training.
• Select, contract, and manage vendors and CROs, including central labs, data management providers, and technology partners.
• Monitor vendor performance, adherence to timelines, and deliverables in accordance with study plans and quality standards. • Develop and maintain a study-specific Risk Management Plan.
• Identify, monitor, and mitigate project risks, including protocol deviations, site issues, or compliance concerns.
• Support protocol development, study design discussions, and ensure alignment with scientific and operational goals. • Assist in the development of manuscripts, conference abstracts, and publications derived from trial data.
• Collaborate with site teams to implement patient recruitment, engagement, and retention strategies.
• Promote inclusive research practices that support diverse participant enrollment and reduce barriers to access.
• Track and reconcile project expenditures; oversee financial reporting and milestone payments.
• Contribute to grant writing, funding proposals, and reporting to funding agencies or donors as needed.
Skills
• Demonstrated ability to build, lead, and mentor high-performing project teams. Skilled in motivating and inspiring others, effectively delegating responsibilities, and making timely, high-quality decisions in complex clinical settings.
• Recognized for earning the trust and confidence of diverse stakeholders. Possesses a quick learning aptitude, managerial courage, emotional resilience, and a proactive mindset, particularly in dynamic and fast- paced environments.
• Deep knowledge of Indian clinical trial regulations and a comprehensive understanding of global standards, including ICH-GCP and CDSCO guidelines. Committed to upholding the highest standards of regulatory and ethical compliance.
• Strong grasp of clinical operations, project budgeting, and resource management. Demonstrates a continuous improvement mindset, with a focus on quality assurance, operational efficiency, and pragmatic problem-solving.
• Exceptional ability to negotiate, influence, and align cross-functional teams and external partners. Approaches challenges with a collaborative, solution-oriented mindset that fosters consensus and drives results.
Project Associate – II
No of post : 01
Name of the Project : Sepsis-related mortality in neonates in India: A multi-disciplinary, multi- institutional research program for context -specific solutions
Emoluments : Rs. 28,000 + HRA
Age : 35 years
Essential qualifications and work experience :
• Graduate degree (3 years) in Life Sciences with a minimum of 2 years of post-qualification experience in clinical research, OR
• Professional degree in MBBS, BDS, BVSc, BAMS, BHMS, BUMS, BSMS, BNYS, B.Sc. Nursing, BPT, B.Pharm, OR
• Postgraduate or Ph.D. in Life Sciences.
• Good Clinical Practice (GCP) certification is mandatory.
Job profile
The Project Associate plays a key role in supporting the execution and management of clinical trials and research studies across all phases. Reporting to the Chief–CPM and Project Manager, the role ensures efficient day-to-day research operations, accurate maintenance of regulatory and study documentation, and effective coordination of communication and logistics among study stakeholders. The incumbent is expected to work independently on assigned tasks, anticipate and address potential challenges, and contribute to process improvements.
• Review and develop familiarity with study protocols, including procedures, timelines, eligibility criteria, confidentiality, and privacy protections.
• Perform data and process monitoring support; ensure maintenance of essential documents at trial sites and CDSA.
• Support on-site co-monitoring visits with the Project Manager (PM) and Quality Manager (QM); willingness to travel across trial sites as required.
• Assist the study team in communicating study requirements to investigators and site staff; provide appropriate training materials and maintain study-specific training logs.
• Support the development of clinical study documents for start-up and other project requirements; assist in preparing submissions for regulatory and ethics committee (EC) approvals.
• Create, maintain, and periodically review the Trial Master File (TMF), Investigator Site Files (ISF), and related systems/tools for accuracy, completeness, and GCP compliance.
• Participate in project-related meetings; assist with agenda preparation, presentations, minutes, and tracking of action items.
• Assist with preparation, handling, distribution, filing, version control, and archiving of study documentation as per SOPs and project requirements.
• Maintain and update regulatory/ethics submission trackers; follow up on approvals and site compliance documentation.
• Support safety reporting by tracking and forwarding SAEs/AEs to the relevant study teams.
• Coordinate study logistics, including shipment and tracking of clinical supplies, kits, equipment, and courier activities.
• Assist with eCRF/EDC management by monitoring data entry, resolving queries, and coordinating with data management.
• Maintain delegation of authority logs and ensure investigator/site staff training certifications are up to date.
• Support audit and inspection readiness; assist with CAPA documentation and tracking.
• Provide general administrative and project support, including maintaining trackers, study contact lists, meeting schedules, and inter- departmental coordination.
Skills
• Strong written and verbal communication skills in English.
• Proficiency in MS Office (Word, Excel, PowerPoint, Outlook) and working knowledge of project management tools.
• Ability to work independently with minimal supervision as well as collaboratively in a team environment.
• Flexible, organized, and able to work effectively under pressure while maintaining integrity.
The applications will be scrutinised/shortlisted and processed for further selection.
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.
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.
1. Documents to be kept handy before filling up the online application: (all the documents except
(i) should be in pdf format) :
i) A soft copy of your passport size photo and signature. (jpeg/jpg/png format)
ii) A comprehensive CV containing details of qualification, positions held, professional experience / distinctions etc.
iii) Matriculation certificate (equivalent to 10th Standard) / Mark sheet
iv) Intermediate certificate (equivalent to 12th Standard) / Mark sheet
v) Graduation/Diploma degree certificate / Mark sheet
vi) Post-Graduation degree certificate & Mark sheet (if applicable)
vii) PhD degree/certificate (if applicable)
viii) Relevant experience certificates (if applicable)
ix) Caste / Disability certificate in the format prescribed by the Govt. of India, if applicable.
Procedure for filling up online application :
i) The eligible and interested candidates may apply online at the Institute’s website. Applications through
any other mode will not be accepted.
ii) The following will be the step wise procedure-
A) Step 1 : Details of applicant
B) Step 2 : Uploading of documents
C) Step 3 : Payment of application fee
• The payment can be made by using Debit Card / Credit Card / Internet Banking/ UPI.
• Once payment is made, no correction / modification is possible
• Candidates are requested to keep a copy of the provisional receipt forfuture reference.
• Fee once paid shall not be refunded under any circumstances.
• Details of fees to be paid are as shown be
1. Unreserved, OBC & EWS candidates : Rs. 590/-
2. SC/ST/Women/PwBD : Rs 118/-
D) Step 4 : Submission of application form
iii) On successful submission of application, an auto-generated email containing the reference number will be sent to the email address provided. Please keep a note of the reference number for future correspondence. iv) Candidates are required to keep a printout of the online application form by using the print button on the dashboard for future reference.
v) Candidates must ensure that he / she fulfils all the eligibility criteria as stipulated in the advertisement. If it is found that he / she does not fulfil the stipulated criteria during the recruitment process, the candidature of the candidate will be cancelled. If the same is noticed after the appointment, the candidate will be terminated following due process.
vi) Incomplete applications shall be summarily rejected and no correspondence in this regard shall be entertained.
vii) In case of difficulty in filling up the online form, please send e-mail to personnel@thsti.res.in along with the screenshot of the error displayed (if any).
Date of walk-in interview : 10th November 2025 @09:00 AM
at THSTI, NCR Biotech Science Cluster, 3rdMilestone, Faridabad-Gurugram Expressway, Faridabad – 121001.
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