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
Number of the 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
Minimum Educational Qualification and Experience : 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 timely delivery of milestones while maintaining quality, compliance, and scientific integrity. The role requires cross-functional leadership, strong operational oversight, and effective problem-solving to support complex clinical research programs.
Key Responsibilities :
• Lead cross-functional coordination to develop and maintain project plans and timelines, and ensure clear communication with investigators, site teams, and other stakeholders.
• Monitor data, processes, and documentation through onsite visits and remote oversight to ensure trial quality and data integrity.
• 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.
• Work with investigators and site teams to monitor study progress, support protocol or operational amendments, and implement participant recruitment and retention strategies.
• Coordinate regulatory and ethics submissions, amendments, and responses to queries to ensure timely approvals.
• Support coordination with sponsors, collaborators, and external stakeholders for compliance, reporting, and study execution.
• Manage project budgets and track expenditures to ensure alignment with approved financial plans and study milestones.
• Support implementation and maintenance of processes related to resource planning, study administration, monitoring, and documentation, under the supervision of the Chief - Clinical Portfolio Management (CPM).
• Support protocol development, study design discussions, and ensure alignment with scientific and operational goals.
• Coordinate the development and management of essential study documents, including study protocols, Case Report Forms (CRFs) and study manuals, ensuring timely review, approval, and distribution.
• Manage regulatory documentation workflows, including distribution, collection, and tracking, ensuring compliance and audit readiness.
• Ensure adherence to approved study protocols and applicable regulatory and ethical requirements.
• Address operational and site-level challenges to ensure continuity and quality of study conduct.
• Develop and maintain a study-specific risk management plan, and identify and track project risks, including protocol deviations and site issues, ensuring appropriate mitigation actions.
• Support identification, documentation, and escalation of protocol deviations, and support audit readiness and audit processes, including coordination of Corrective and Preventive Actions (CAPAs). • Liaise with the Steering Committee and Data Safety Monitoring Board (DSMB) to support study oversight and ensure compliance with applicable regulatory and ethical requirements.
• Coordinate and track Serious Adverse Event (SAE) reporting and follow- up, and support DSMB reviews and safety-related actions.
• Develop and deliver project- and protocol-specific training, and provide ongoing guidance and operational support to project staff, including participation in CDSA training initiatives.
• Work with data management and other functions to monitor project milestones, identify issues and ensure timely progress.
• Support the use and optimization of clinical trial management systems (CTMS), electronic data capture (EDC), and eTMF systems.
• Act as the point of contact for system usage, troubleshooting, and user support.
• Select and manage vendors and CROs, including central labs, data management providers, and technology partners, and monitor their performance against timelines and deliverables.
• Promote inclusive research practices that support diverse participant enrolment and reduce barriers to access.
• Support reporting to funding agencies and contribute to grant-related documentation, as required.
• Undertake additional responsibilities within the Clinical Portfolio Management team as required by project deliverables or organisational needs.
Skills
• Demonstrated ability to lead and manage project teams, including delegation of responsibilities and timely decision making in clinical research settings.
• Ability to work effectively with diverse stakeholders and maintain professional working relationships across functions.
• Strong knowledge of Indian clinical trial regulations and applicable global standards, including ICH-GCP and CDSCO guidelines.
• Understanding of clinical operations, project budgeting, and resource management with focus on quality and operational efficiency.
• Ability to coordinate, influence, and align cross-functional teams and external partners to achieve project objectives.
Date of walk-in interview : 10th June 2026 @09:00 AM at THSTI, NCR Biotech Science Cluster, 3rd Milestone, Faridabad-Gurugram Expressway, Faridabad – 121001
Clinical Research Associate
Number of the 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. 49,000/- + HRA
Age : 40 years
Minimum Educational Qualification and Experience : Essential qualifications and work experience :
• Bachelors in Life Sciences with minimum three (3) years of relevant clinical trial monitoring experience / Clinical Trial Coordinator experience OR
• Master’s degree/ PG Diploma in Life Sciences/Pharmacy/ Public Health/ Healthcare or related discipline with minimum two (2) years of relevant clinical trial monitoring experience.
• MBBS/ BDS/ BHMS/ BAMS/ BPT preferred (relevant experience as above)
Desirable qualifications and work experience :
Job profile
The primary responsibility of the CRA will be laboratory monitoring, including oversight of sample-related processes, laboratory documentation, and laboratory data quality, with additional responsibility for monitoring other study processes as required. The role will focus on ensuring that laboratory procedures, sample handling, documentation, and related data are conducted in accordance with the study protocol, SOPs, applicable quality standards, and ethical and regulatory requirements. In addition, the CRA will support monitoring of other key study processes, including source documentation, data quality, and protocol compliance at the study site.
Key Responsibilities
• Primarily monitor laboratory processes related to the study, including sample collection, processing, labelling, storage, transport, tracking, testing workflow, and documentation, to ensure compliance with protocol requirements, SOPs, and applicable quality standards, including GCLP principles where relevant.
• Review laboratory records, logs, and supporting documentation to ensure completeness, accuracy, traceability, and readiness for audit or inspection.
• Monitor laboratory data and its linkage with clinical and study records to ensure consistency, completeness, and data integrity.
• Conduct site monitoring visits from initiation through closeout, ensuring trials are conducted in compliance with the study protocol, GCP guidelines, SOPs, and applicable regulatory requirements.
• Verify study data through source document review and source data verification to ensure consistency between source records, CRFs, laboratory records, and study databases.
• Monitor participant enrolment, follow-up procedures, and study documentation, with particular attention to protocol compliance and completeness of records.
• Identify and document protocol deviations, process gaps, laboratory non- conformances, and data discrepancies, and ensure timely follow-up and escalation to the Project Manager or Study Leadership, as appropriate.
• Support training or retraining of site and laboratory staff on study-specific procedures, documentation requirements, and quality practices, where needed.
• Prepare monitoring visit reports, follow-up letters, trackers, and other relevant documentation in a timely manner.
• Ensure maintenance of Investigator Site File (ISF) and essential documents at site, including completeness, accuracy, and audit readiness.
• Maintain regular communication with investigators, study coordinators, laboratory teams, and internal study management teams to support smooth study conduct.
• Perform quality checks across laboratory and other relevant study processes to support protocol adherence and data quality.
• Contribute to audit readiness, close-out activities, and archiving of essential study and laboratory documentation.
• Collaborate with study coordinators, laboratory teams, internal study management teams and other internal departments on cross-functional initiatives and project requirements.
Skills
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint, Outlook).
• Strong knowledge of ICH-GCP, GCLP, and regulatory guidelines.
• Excellent documentation, communication, and organizational skills.
• Ability to travel frequently to assigned clinical trial sites.
• Detail-oriented with effective time management skills and ability to manage multiple tasks and priorities efficiently.
Date of walk-in interview : 11th June 2026 @09:00 AM at THSTI, NCR Biotech Science Cluster, 3rd Milestone, Faridabad-Gurugram Expressway, Faridabad – 121001
Quality Manager
Number of the post : 01
Name of the Project : Improving maternal and neonatal outcomes using imaging data science
Emoluments : Rs. 56,000/- + HRA
Age : Up to 35 years
Minimum Educational Essential qualifications and work experience : • Post Graduate Degree, including the integrated PG degrees.
Desirable
• The candidate must possess a valid GCP certificate.
• Two (2) years of work experience as a Clinical Research Associate/ Clinical Research Coordinator/ Site Manager in Clinical Research.
Job profile
• The Quality Manager is responsible for the oversight, management and operational execution of assigned clinical studies and trials under the supervision of the Project Manager and the Chief-CPM.
• The Quality Manager must ensure the integrity of the trial by monitoring data, processes, and documentation both onsite and remotely.
• Ensure high-quality standards on delivery of key tasks with adherence to project timelines and deliverables.
• Conducting site qualification, initiation, monitoring, and close-out visits for designated clinical trial and willing to travel to all clinical sites across India on short notice, and stay for extended periods as required.
• Understand the requirements and frameworks of the various regulatory bodies such as DBT, ICMR, HMSC etc, and guide the project conforming to those requirements.
• Responsible for the establishment of quality assurance procedures and time points across various aspects of the overall project functioning.
• Prepare a risk assessment and mitigation plan for the study and, ensure its implementation.
• Establishment of procedures to ensure adherence to trial protocols and administrative requirements. • Develop project specific and protocol specific training or as requested.
• Monitoring the trial progress to ensure compliance with and adherence to the project plan and to identify, evaluate and rectify problems.
• Work with the Investigators to ensure that the trial is meeting its targets, is producing meaningful output and to predict and plan any changes that warrant requests to changes in protocol, funding, or timelines.
• Development, approval, and distribution of study-related documents including Case Report Forms (CRF’s), study protocols, study manuals, and other study tools to investigational sites and review committees.
• Work with data management and other departments to track progress, milestones and the challenges.
• Communicate to team members the scope of work, timeline and project goals, technical information or update.
• Provide guidance and operational area training for project team members and staff as required
• Responsible for the training, task allocation and evaluation of the performance of the study monitors.
• Any other assignments with the Clinical Portfolio Management team, based on project deliverable or exigencies.
Skills
• Ability to work independently with minimal guidance as well as collaboratively within a team setting.
• Leadership skills that include the ability to build effective project teams, ability to motivate others, delegate, drive and timely/quality decision- making
• Business/ Operational skills that include a commitment to quality management and problem-solving.
• Effective communication skills that ensure the provision of timely and accurate information to stakeholders. Proficient in English, Strong written and oral communication skills.
• Proficient in computer literacy in Excel, Word, PowerPoint, and Access.
• Good writing skills, including the ability to develop and deliver presentations, prepare technical reports, manuscripts, monitoring plans and SOPs.
• Comprehensive understanding of Indian Clinical Trials Regulations, ICH and CDSCO Good Clinical Practice
• Knowledge of regulations and guidelines pertaining to the conduct of clinical trials/ studies on human subjects.
• Personal qualities that include the ability to gain trust and confidence with a variety of clients, good learning ability, managerial courage, ability to prioritize workload, action-oriented and flexible to accommodate in changing environment.
• Influencing skills including negotiation and teamwork.
Date of walk-in interview : 10th June 2026 @09:00 AM at THSTI, NCR Biotech Science Cluster, 3rd Milestone, Faridabad-Gurugram Expressway, Faridabad – 121001
Sr. Project Associate
Number of the post : 01
Name of the Project : INDIGO Effective and Affordable flu Vaccine for the world
Emoluments : Rs. 42,000/- + HRA
Age : 40 years
Minimum Educational Qualification and Experience : • Post graduate degree in Life Sciences with a minimum of two years of experience in clinical research, OR
• Professional degree in MBBS, BDS, BVSc, BAMS, BHMS, BUMS, BSMS, BNYS, B.Sc. Nursing, BPT, B. Pharm, with a minimum of one year of experience in clinical research OR
• PhD in Life Sciences with experience in clinical research. Good Clinical Practice (GCP) certification is mandatory.
Job profile
The Senior Project Associate plays a pivotal role in supporting the execution and management of clinical trials across all stages. Working under the direction of the Project Manager and study monitors, they ensure the smooth operation of daily trial activities, maintain regulatory and trial documentation, and coordinate communication and logistics across study stakeholders. This role is expected to work independently on assigned tasks, proactively identify potential issues, and propose process improvements.
Key Responsibilities :
Clinical Trial Support & Documentation
• Coordinate and track the distribution and reconciliation of clinical trial supplies, laboratory kits, and investigational products to investigational sites.
• Ensure timely delivery and tracking of essential study documents and materials in accordance with study timelines and site activation plans.
• Maintain and regularly update trial tracking tools (e.g., enrollment logs, regulatory document trackers, training logs).
Regulatory & Site Start-up Support
• Support CRAs and site staff in the collection, review, and tracking of essential regulatory documents for ethics committee and regulatory authority submissions.
• Assist in preparing site initiation packages and supporting site readiness for activation.
• Liaise with regulatory, legal, and contracts departments to ensure timely processing of site contracts and confidentiality agreements. Trial Master File (TMF) Oversight
• Lead TMF set-up and ongoing maintenance, ensuring completeness, accuracy, and audit-readiness of clinical documentation.
• Perform periodic TMF quality control (QC) checks and contribute to TMF metrics and reconciliation activities.
• Support the development and implementation of TMF filing plans and oversight reports. Meeting Coordination & Communication
• Schedule, coordinate, and document clinical team meetings, site communications, and teleconferences; maintain meeting agendas and minutes.
• Assist with the organization and execution of investigator meetings, including logistics, preparation of materials, and follow-up documentation.
Data & Site Management
• Support CRAs with clinical data flow, Case Report Form (CRF) tracking, and resolution of data queries with investigational sites.
• May accompany CRAs on monitoring visits to gain on-site experience and provide additional support during critical phases of the trial. Cross-functional & Operational Support • Serve as the central point of contact for the clinical team regarding project- specific communications and documentation.
• Collaborate with Clinical Portfolio Management, Regulatory Affairs, Data Management, and Quality Assurance to ensure alignment of deliverables.
• Support budget tracking, invoice verification, and financial documentation coordination related to trial expenses and vendor contracts.
Quality & Compliance
• Ensure adherence to ICH-GCP, applicable regulatory requirements, and internal Standard Operating Procedures (SOPs).
• Participate in internal and external audits and inspections as needed; support audit readiness and CAPA (Corrective and Preventive Action) implementation.
• Contribute to internal quality initiatives and process optimization efforts.
Skills
• Strong understanding of ICH-GCP guidelines and clinical trial lifecycle.
• Experience working with electronic Trial Master File (eTMF), Clinical Trial Management Systems (CTMS), and document management platforms.
• Excellent communication, organizational, and problem-solving skills.
• Detail-oriented with the ability to manage multiple tasks and prioritize effectively.
• Proficient in MS Office Suite (Word, Excel, PowerPoint, Outlook).
Date of walk-in interview : 11th June 2026 @09:00 AM
at THSTI, NCR Biotech Science Cluster, 3rd Milestone, Faridabad-Gurugram Expressway, Faridabad – 121001
NOTE
1) The candidates applying for the above mentioned 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.
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