RECRUITMENT NOTICE NO.: THS-C/RN/13/2025 Dated: 14th August 2025
RECRUITMENT NOTIFICATION
1. BRIC-Translational Health Science and Technology Institute (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.
2. BRIC-THSTI has built several inter-institutional collaborations and connectivity with industry
supported by well-trained teams of research and laboratory staff. THSTI has established various
centres namely (a) Centre for Maternal and Child Health, (b) Centre for Virus Research,
Therapeutics and Vaccines (c) Centre for Tuberculosis Research (d) Centre for Microbial
Research, (e) Centre for Immunobiology and Immunotherapy (f) Centre for Drug Discovery (g)
Clinical Development Services Agency (h) Computational and Mathematical Biology Centre (i)
Centre for Bio-design and Diagnostics. These centres are strengthened by many core facilities
viz. Bioassay Laboratory, Biorepository, Biosafety Level-3 Lab, Data Management Centre,
Immunology Core laboratory, Multi-Omics facility, Experimental Animal Facility, Vaccine design
and Development facility, School of Innovation in Bio design etc. that serve as huge resources
for the research programmes of THSTI and also the National Capital Region Biotech Science
Cluster and other academic and industrial partners. BRIC-THSTI trains the next generation of
scientific leaders through many ambitious and globally competitive academic courses which
promotes research and innovation through multi-disciplinary academia-industry partnerships
3. This recruitment is to fill up the vacancies of BRIC-THSTI under the following projects:
Educational Qualification and Experience
required for the post:
1. Name of the
post Project Manager
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 problemsolving.
• 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.
2. Name of
the post Senior Clinical Research Associate
Number
of the post
Three (03)
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
Location Based at AIIMS Raipur and travel to 10 District Hospitals in
Chhattisgarh
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.
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.
3. Name of
the post Assistant Data Manager (Level II)
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 postqualification 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 postqualification 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
4. Name of the
post -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
Location THSTI
Minimum
Essential:
• Master’s degree in any field preferably in science, with 4 years of postqualification experience in clinical data management/clinical
Educational Qualification
and Experience
research/operations/MIS/data analysis/IT/computer science/healthcare
field
OR
• Graduation degree in any field preferably in science, with 6 years of postqualification 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
Responsibilities:
• 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 studyrelated 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
For posts mentioned above-
➢ Last date for receipt of online
application for posts: 03 September 2025.
➢ The applications
will be scrutinised/shortlisted and processed for further selection.
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