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 of BRIC-THSTI under the following projects :
Project Manager - 01 post
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
Emoluments : INR 90,000 per month
Age : Up to 45 years
Location : Based at AIIMS Raipur and travel to 10 District Hospitals in Chhattisgarh
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 / PG Diploma 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 concepts using standard tools and templates.
Job profile
• The 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 :
• Oversee and manage the performance of the project team, ensuring effective collaboration and accountability across functions.
• 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.
• Develop and analyse real-time performance dashboards to track site metrics, data quality indicators, issue resolution trends, and project milestones.
• 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
• 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.
Senior Clinical Research Associate - 03 posts
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
Emoluments : INR 75,000 per month
Age : Up to 40 years
Location : Based at AIIMS Raipur and travel to 10 District Hospitals in Chhattisgarh
Minimum Educational Qualification and Experience
Essential qualifications and work 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.
Job profile
• 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.
Assistant Data Manager (Level II) - 01 post
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
Emoluments : INR 90,000 per month
Age : 45 years
Location : THSTI
Minimum Educational Qualification and Experience
Essential qualification and work experience :
• 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 qualification and work experience :
Diploma in Information Technology/ Computer Applications/ Clinical Data Management. Familiarity with industry standard CDMS and some programming skills.
Demonstrated experience of developing Clinical Study Data Management documents
Job profile
• Overall responsible for taking lead of all the data management activities for the mentioned study, timely delivery of key tasks, while maintaining high quality standards.
• Escalate concerns related to variables that are critical to study quality and outcomes.
• Develop and implement automation solutions to reduce manual errors and improve process efficiency.
• Generate routine and ad-hoc reports to track study progress, identify potential issues, and flag non-compliance trends.
• Serve as the primary point of contact for all data-related communications with the sponsor and clinical sites.
• Collaborate with cross-functional project teams to support the planning, execution, and closure of study-specific data management tasks.
• Conduct database testing and audits as part of internal quality control measures.
• Prepare and review essential data management documentation, including the Data Management Plan (DMP), Data Validation Plan (DVP), Annotated CRF, and Data Entry Guidelines.
• Manage query resolution, data cleaning, interim/final data freezes, and data archiving activities.
• Process and transform raw data to ensure accuracy, completeness, and consistency.
• Lead the development of clean, analysis-ready datasets in compliance with data protection and regulatory standards.
• Generate interim study reports and support data extraction in coordination with the sponsor and coordinating centers.
• Apply logical reasoning and robust data management techniques to ensure data integrity and validity.
• Utilize data visualization tools (e.g., Tableau, Power BI, advanced Excel) to design interactive dashboards and generate visual insights based on project needs to support decision-making and reporting.
• Coordinate the secure archiving of study databases and associated documentation.
• Develop, implement, and maintain Standard Operating Procedures (SOPs) and work instructions; provide training to study staff as required.
• Demonstrate hands-on experience in both paper-based and electronic CRF (eCRF) development and maintenance.
• Represent the data management function in internal cross-functional meetings and external client discussions.
• Ensure strict adherence to data security protocols and participant confidentiality throughout the study.
• Apply working knowledge of CDM best practices, database development standards, and industry frameworks including CDISC and SDTM.
• Supervise site-level data management activities to ensure adherence to protocol and study timelines.
Skills
• Good management & leadership skills.
• IT literate (experience with Microsoft based applications, data visualization tools and other data management applications).
• Must have experience in handling databases and query management.
• Client focused approach to work
• Meticulous attention to detail.
• Must be able to work independently but seek guidance when necessary.
• Team player with outstanding inter-personal, negotiation skills and organizational skills.
• A flexible attitude with respect to work assignments and new learning.
• Effective time management in order to meet metrics or team objectives.
• Commitment to project and team goals.
• Demonstrated ability to solve complex tasks and complete work on time
• Commitment to deliver high-quality work consistently
• Ability to model behavior and ethics in line with CDSA Mission and Vision
Assistant Data Manager (Level I)
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
Emoluments : INR 60,000 per month
Age : 40 years
Location : THSTI
Minimum Educational Qualification and Experience
Essential :
• Master’s degree in any field preferably in science, with 4 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 6 years of post-qualification experience in clinical data management/clinical research/operations/MIS/data analysis/IT/computer science/healthcare field
Desirable :
Diploma in Information Technology/ Computer Applications
Job profile
• Assist in drafting, updating, and maintaining data management documents including the Data Management Plan (DMP), Edit Checks Document, Annotated CRF, Data Entry Guidelines, and SOPs.
• Contribute to the design and development of paper Case Report Forms and electronic Case Report Forms (CRFs).
• Collaborate with the Data Science team in database development, edit check implementation, and database testing.
• Enter and manage test data to support screen and database validation processes.
• Support data cleaning activities including query management, interim and final data freezes, and data archival.
• Collaborate with other project team members to support the set-up, maintenance, and closure of data management activities.
• Assist in preparing interim reports, performing data extraction, and supporting ongoing data review.
• Apply working knowledge of data standards (e.g., CDISC, SDTM), clinical data management practices, and SOPs.
• Provide training to site-based data entry operators, if required.
• Support data entry and data reconciliation activities as assigned.
• Assist in preparing analysis-ready datasets and ensuring compliance with data protection and privacy standards.
• Contribute to the creation of reports and dashboards to monitor study performance.
Provide general support to the Data Science team for any additional study- related tasks.
Skills
• Familiarity with GCP, 21 CFR 11, regulatory requirements and data standardization guidelines.
• IT literate (experience with Microsoft based applications and other CDMS applications).
• Must understand clinical research and familiarity with clinical data management functions.
• Good interpersonal, verbal and written communication skills.
• A flexible attitude with respect to work assignments and new learning.
• Effective time management in order to comply to timelines.
• Commitment to project and team goals.
• Must be able to work independently but seek guidance when necessary.
• Demonstrated ability to solve complex tasks and complete work on time
• Must be a team player
• Ability to model behavior 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.
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
2. 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 for future reference.
• Fee once paid shall not be refunded under any circumstances.
• Details of fees to be paid are as shown below.
Unreserved, OBC & EWS candidates : Rs 590/-
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).
RECRUITMENT NOTICE NO : THS-C/RN/13/2025
Last date for receipt of online application for posts : 03 September 2025
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