Opportunity for Pharmacy and Life Sciences Graduates at Clinical Development Services Agency, THSTI

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 Scientist - III
Post Code : 01
Number of the post : 01
Name of the Project : INDIGO Effective and Affordable Flu Vaccine for the world
Emoluments : Rs. 78,000/- + HRA
Age : Up to 45 years
Minimum Educational Qualification and Experience : Essential qualifications and work experience :
• Master's or Doctoral Degree in Science or Technology from a recognised University or equivalent AND
• Seven years' experience in Research and Development in Industrial and Academic Institutions, or Science and Technology Organisations, and Scientific activities and services
Desirable qualifications and work experience :
• Experience of clinical trial or public health project management in a recognised organisation/institute (academic clinical trials unit, CRO, pharmaceutical, biotechnology, or device company).
• Demonstrable experience of line management, project management concepts, and ability to understand, explain and communicate project concepts using standard tools and templates
Job profile
The Project Scientist – III (Project Manager) oversees, manages, and executes 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 :
• The project manager will manage the performance of the project team working on projects.
• The management and cross-functional coordination of the project and work closely to develop and maintain the overall project plan and timelines, communicate project expectations to the respective resource/consultant and manage the overall project budget.
• Support the team in the implementation of systems for resource planning, study/trial administration, implementation, oversight monitoring, quality assurance, documentation and record keeping.
• 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
• Understand the requirements of the various controlling bodies, agencies and frameworks, guiding the project in conforming to those requirements and coordinating any necessary audit processes
• Liaison with the Steering Committee and DSMB with a particular view on compliance with Research Governance, Good Clinical Practice, Data Protection and Ethical Requirement
• 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 (CRFs), study protocols, study manuals, and other study tools to investigational sites and review committees
• Manage distribution, collection and tracking of regulatory documentation to ensure compliance with regulatory and project requirements and audit readiness
• 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 updates.
• Provide guidance and operational area training for project team members and staff as required
• Conduct site qualification, initiation, monitoring, and closeout visits for assigned studies; willing to travel to trial sites across India at short notice and for extended periods.
• Prepare, oversee, and track submissions to ethics committees, regulatory authorities, and other governing bodies; manage amendments, renewals, and responses to queries.
• Coordinate and support audit readiness and audit processes, including development and implementation of Corrective and Preventive Actions (CAPAs).
• Evaluate, implement, and manage clinical trial technology systems, including CTMS, EDC, and eTMF; act as the point of contact for system integration, troubleshooting, and user training.
• Select, contract, and oversee vendors, CROs, and third-party providers (e.g., central labs, technology partners); track performance, timelines, and deliverables against agreed quality standards.
• Develop, implement, and maintain a study-specific Risk Management Plan to proactively identify, mitigate, and monitor protocol deviations, site issues, and compliance concerns.
• Collaborate in the preparation of publications, manuscripts, and conference abstracts derived from study data. • Work with site teams to implement participant recruitment, engagement, and retention strategies, including initiatives to improve diversity and equitable access in trials.
• Track and reconcile project expenditures, oversee milestone-based payments, and ensure alignment with the approved project budget and funding agreements.
• Contribute to grant writing, preparation of funding proposals, and preparation of reports to funding agencies, sponsors, and donors.
• Develop and analyse performance dashboards to track site metrics, data quality, issue resolution trends, and overall project performance in real time.
• Willingness to travel frequently to trial/study sites using various eligible travel modes, including public and private transport across states in India.
• Faculty for training projects conducted by CDSA
• Any other assignment with the Clinical Portfolio Management team, based on project deliverables or exigencies
Skills
• Leadership skills that include the ability to build effective project teams, the ability to motivate others, delegation, drive and timely/quality decision making
• Personal qualities that include the ability to gain trust and confidence with a variety of clients, good learning ability, managerial courage, action- oriented and resilience in a fast- paced and rapidly changing environment
• Comprehensive understanding of Indian Clinical Trials Regulations, ICH and CDSCO Good Clinical Practice
• Business/ Operational skills that include commitment to quality management and problem-solving
• Influencing skills, including negotiation and teamwork
• Effective communication skills that include the provision of timely and accurate information to stakeholders, proficient in English, strong written and oral communication skills
• Computer literacy in Word, Excel, PowerPoint, Access or other trial management systems
• Ability to develop and deliver presentations, prepare technical reports and contribute effectively to manuscripts
• Ability to develop and implement monitoring plans and SOPs
• Ability to make evaluative judgments, remain flexible as projects and priorities change
• Demonstrated ability to prioritise workload to meet multiple deadlines
• Ability to work independently with minimal guidance as well as collaboratively within a team setting
• Knowledge of regulations and guidelines pertaining to the conduct of clinical trials/ studies on human subjects

Date of walk-in interview : 28th January 2026 @09:00 AM
at THSTI, NCR Biotech Science Cluster, 3rd Milestone, Faridabad-Gurugram Expressway, Faridabad – 121001

Data Manager
Post Code : 02
Number of the post : 01
Name of the Project : INDIGO Effective and Affordable Flu Vaccine for the world
Emoluments : Rs. 67,000/- + HRA
Age : Up to 40 years
Minimum Educational Qualification and Experience : Essential qualifications and work experience :
• Ph.D. in any field preferably in science, with 2 years of post-qualification experience in clinical data management/ clinical research/ operations/MIS/data analysis/IT/computer science/ healthcare field OR
• 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
Key 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, WHO Drug).
• 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.
Date of walk-in interview : 29th January 2026 @09:00 AM at THSTI, NCR Biotech Science Cluster, 3rd Milestone, Faridabad-Gurugram Expressway, Faridabad – 121001

Principal Project Associate
Post Code : 03
Number of the post : 01
Name of the Project : INDIGO Effective and Affordable Flu Vaccine for the world
Job Location : Christian Medical College (CMC), Vellore
Emoluments : Rs. 49,000/- + HRA
Age : Up to 40 years
Minimum Educational Qualification and Experience : Essential qualifications and work experience :
(i) Master’s Degree in Natural Sciences or Agricultural Sciences, OR Bachelor’s Degree in Engineering, Technology, or Medicine from a recognised University or equivalent; and
(ii) Eight (08) years’ experience in Research and Development in Industrial and/or Academic Institutions or Science and Technology Organisations, including scientific activities and services. OR
(i) Doctoral Degree (PhD) in Science / Engineering / Technology / Pharmaceutical Sciences / MD / MS from a recognised University or equivalent; and
(ii) Four (04) years’ experience in Research and Development in Industrial and/or Academic Institutions or Science and Technology Organisations, including scientific activities and services.
Desirable qualifications and work experience :
• Experience of clinical trial or public health project management and monitoring in a recognised organisation/institute (academic clinical trials unit, CRO, pharmaceutical, biotechnology, or device company).
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 organisational and problem-solving skills. Effective time management skills and ability to manage competing priorities.

Senior Clinical Research Associate
Post Code : 04
Number of the post : 02
Name of the Project : Effect of Immediate Kangaroo Mother Care (iKMC) on neonatal mortality and culture-positive sepsis in low-birth-weight neonates in district hospitals in Chhattisgarh, India: a stepped-wedge cluster randomized trial
Job Location : Christian Medical College (CMC), Vellore
Emoluments : Rs. 75,000/-
Age : Up to 40 years
Minimum Educational Qualification and Experience :
• Bachelor's in Life Sciences with a minimum of three years of relevant clinical trial monitoring 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 a minimum of 2 years of relevant clinical trial monitoring 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.
Desirable qualifications and work experience :
• The Sr. Clinical Research Associate (CRA) 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.
• Collaborate cross-functionally with clinical operations, data management, safety, and regulatory teams.
• Maintain effective communication with investigators and site staff to ensure study success.
• Frequently travel to assigned trial/study sites by eligible modes of travel, including city and state public transportation, own transportation, train travel, or private mass transport services, including standard and luxury buses.
Skills
• Proficient in computer applications, with demonstrated expertise in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
• Strong knowledge of ICH-GCP, GCLP, and regulatory guidelines.
• Excellent documentation, communication, and organizational skills.
• Detail-oriented with effective time management skills and ability to manage multiple tasks and priorities efficiently.

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 below :
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).

For post mentioned in Sr. No. 3 & 4 :
Last date for receipt of online application for posts : 04th February 2026.
The applications will be scrutinised/shortlisted and processed for further selection

NOTE :
1) The candidates applying for the post mentioned on S. No. 1 & 2 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.