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
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 : 35 years
Minimum Educational Qualification and Experience
• Graduate degree (3-year course) 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
• Postgraduate or PhD in Life Sciences with a minimum of one year of 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).
Principal Project Associate
Number of the post : 01
Name of the Project : INDIGO Effective and Affordable flu Vaccine for the world
Emoluments : Rs. 49,000/- + HRA
Age : 35 years (relaxation as per Government of India rules)
Minimum Educational Qualification and Experience
• Bachelor's in medical sciences with minimum three years of relevant clinical trial monitoring experience or clinical trial/study coordinator, or clinical trial/study associate experience. OR
• Master’s degree/ diploma, life sciences, pharmacy, public health, healthcare or other related discipline with minimum 2 years of relevant clinical trial monitoring experience or clinical trial/study coordinator, or clinical trial/study associate experience. OR
• MBBS/ BDS/ BHMS/ BAMS/ BPT with a minimum of 2 years of relevant clinical trial monitoring or clinical trial/study coordinator, or clinical trial/study associate experience.
Job profile
• The Principal Project Associate/ Clinical Research Associate conducts monitoring visits for the assigned trial protocol and trial sites. Overall, the responsibilities are to ensure that the trial is conducted in accordance with the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.
• Performs site monitoring throughout the trial, which involves visiting the trial sites regularly (site initiation to site closeout) in accordance with the contracted scope of work.
• Performs quality functions and executes quality programs (clinical operations, clinical laboratory) as per GCP/GCLP and regulations
• Completes appropriate therapeutic, protocol and clinical research training to perform job duties.
• Setting up the trial sites such that each center has the trial materials, including the trial drug, while ensuring all trial supplies are accounted for.
• Administers protocol and related trial training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.
• May provide training and assistance to junior clinical staff.
• Creates and maintains appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required trial documentation.
• Manages the progress of assigned studies by tracking regulatory/ IEC submissions and approvals, recruitment and enrolment, CRF completion and submission, and data query generation and resolution.
• Verifying that data entered onto the CRFs is consistent with participant clinical notes (source data/ document verification)
• Writing visit reports.
• Filing and collating trial documentation and reports.
• Archiving trial documentation and correspondence.
• Evaluates the quality and integrity of trial site practices related to the proper conduct of the protocol and adherence to applicable regulations.
• Escalates quality issues to the Quality Manager, Project Manager and/ or senior management.
• Work with Clinical Portfolio Management on other projects as directed and with other internal departments on their requirements as and when required.
Skills
• Computer skills, including proficiency in the use of Microsoft Office applications
• Basic knowledge and ability to apply GCP and applicable regulatory guidelines.
• Strong written and verbal communication skills, including a good command of English, are required.
• Excellent organizational and problem-solving skills.
• Effective time management skills and ability to manage competing priorities.
Data Manager
Number of the post : 01
Name of the Project : INDIGO Effective and Affordable flu Vaccine for the world
Emoluments : Rs. 67,000/- + HRA
Age : 40
Minimum Educational Qualification and Experience
Essential:
• Master’s degree in any field preferably in science, with 6 years of post- qualification experience in clinical data management/ clinical research/ operations/MIS/data analysis/IT/computer science/ healthcare field OR
• Graduation degree in any field preferably in science, with 8 years of post-qualification experience in clinical data management/ clinical research/operations/MIS/data analysis/IT/computer science/ healthcare field
Desirable : • Diploma in Clinical research and clinical data management.
• Familiarity with industry standard CDMS and some programming Skills
• Preparation of Clinical Study Data Management documents
Job profile
Responsibilities
• Clinical Study Protocol understanding and experience in the preparation of Data Management documents - DMP (Data Management Plan), DVP (Data Validation Plan/ Edit Checks Document), Annotated CRF, Data Entry Guidelines etc.
• Prepare data transfer guidelines for external data loads and self-evident correction charts.
• Manage change requests and coordinate approvals from sponsors and stakeholders.
• Design and review Case Report Forms (CRFs/eCRFs) aligned with protocol requirements.
• Oversee and quality check of clinical database setup, validation programming, annotated CRFs, data extract views, and final data listings.
• Ensure adherence to standards such as CDISC, SDTM, and institutional SOPs.
• Reconcile adverse event (AE/SAE) data and integrate medical coding dictionaries (e.g., MedDRA, WHODrug).
• Preparation of Data transfer guidelines for external data load and self- evident correction chart.
• Working knowledge of Query management, data cleaning, data freezing and data archival.
• Maintain strict compliance with GCP, ICH, and data protection regulations.
• Ensure participant confidentiality and secure handling of all clinical trial data.
• Train and supervise site staff in data entry and protocol compliance.
• Sound knowledge of Clinical Database Development tools, logics and techniques and GCDMP
• Generate interim reports and review of listings of data for clinical trial status and data extraction in collaboration with the statistician • Generating ad-hoc reports as needed to support project oversight and decision-making.
• Maintain oversight of data status reports for internal and external communication.
• Maintaining and archiving of clinical study related documents
• Participates in cross functional team meetings & external client meetings as DM representative
• The data manager will ensure that security of all data is maintained and confidentiality of participants is protected.
• Managing requests for data from external third parties – including liaising with internal staff and external collaborators to provide data in a timely and appropriate manner and maintenance of a database detailing the status of such external data requests.
• Knowledge of Biorepository Management Systems (BMS) for tracking specimen status and turnaround time.
• Effective interaction with intra-departments to ensure all required, vital information and documentation is acquired in a timely manner.
• Lead in preparation of datasets for analysis including data cleaning and ensuring compliance with the data protection.
• Development of Standard Operation Procedures and training to the study team
• Supervise DM activities at the clinical site.
Skills
• Good management & leadership skills
• Familiarity with GCP, US-FDA 21 CFR 11, regulatory requirements and data standardization guidelines.
• IT literate (experience with Microsoft based applications and other CDMS applications)
• Must have experience in handling EDC tools
• Validation programming
• Must have understanding of clinical trials and familiarity with clinical data management functions.
• Good interpersonal, verbal and written communication skills.
• Client focused approach to work.
• A flexible attitude with respect to work assignments and new learning.
• Meticulous attention to detail.
• Effective time management in order to meet metrics or team objectives.
• Commitment to project and team goals.
• Must be able to work independently but seek guidance when necessary.
• Team player with outstanding inter-personal, negotiation skills and organizational skills.
• Sense of urgency in completing assigned tasks
• Exhibits a sense of urgency about solving problems and completing work.
• Shows commitment to and performs consistently high-quality work.
• Ability to model behaviors and ethics in line with CDSA Mission and Vision.
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
Walk in Interview
Sr. Project Associate : 01st December 2025
Principal Project Associate : 01st December 2025
Data Manager : 26th November 2025
Time : 09:00 AM
Venue : THSTI, NCR Biotech Science Cluster, 3rd Milestone,
Faridabad-Gurugram Expressway, Faridabad – 121001.
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