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 :
Research Associate (Quality Assurance)
No of 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. 58,280/-
Age : 35 years
Minimum Educational Qualification and Experience :
• Bachelor's in Life Sciences with a minimum of three years of relevant clinical trial monitoring 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 experience.
• MBBS/ BDS/ BHMS/ BAMS/ BPT preferred (Experience as above)
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.
• Ability to travel frequently to assigned trial sites.
• Detail-oriented with effective time management skills and ability to manage multiple tasks and priorities efficient
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. The Research Associate is responsible for the oversight of clinical trial sites to ensure adherence to study protocols, Good Clinical Practice (GCP), and applicable regulatory requirements. This position involves conducting regular monitoring visits, supporting site operations, and maintaining data quality and compliance across all phases of the clinical trial lifecycle.
• 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.
• Set up trial sites, ensuring that investigational products and essential trial supplies are delivered, stored, and documented appropriately.
• Perform quality checks and execute quality assurance process across clinical operations and clinical laboratories in accordance with GCP/GCLP standards.
• Provide training on protocols and trial procedures to site staff and maintain ongoing communication to support study execution and address issues.
• Support clinical staff through guidance and training as and when needed.
• Create, maintain, and submit all required documentation related to site management, monitoring visits, findings, and follow-up actions.
• Track and manage study progress, including regulatory and ethics submissions, patient recruitment and enrolment, CRF completion, and data query resolution.
• Verify data accuracy through source data/document verification to ensure consistency between CRFs and clinical records.
• Prepare detailed monitoring visit reports and contribute to the preparation and archiving of essential trial documents.
• Assess trial site compliance and escalate quality or protocol deviations to the Project Manager or Senior Leadership as appropriate.
• Collaborate with Clinical Portfolio Management and other internal departments on cross-functional initiatives and project requirements.
Program Manager
No of Post : 01
Name of the Project : Improving maternal and neonatal outcomes using imaging data science I
Emoluments : Rs. 67,000/- + 18% HRA = Rs. 79,060/-
Age : Up to 40 years
Minimum Educational Qualification and Experience :
• MBBS/BDS/BVSc with a minimum of three (3) 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.
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.
Job profile
The Program Manager is responsible for overseeing, managing, and executing the operational aspects of assigned clinical studies and 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.
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.
Interested candidates fulfilling the criteria for the Research Associate posts may walk-in for a written test/skill test/interview on 17th June 2025 @09:00 AM at THSTI, NCR Biotech Science Cluster,3rd Milestone, Faridabad-Gurugram Expressway, Faridabad – 121001.
Interested candidates fulfilling the criteria for the Program Manager post may walk-in for written test/skill test/interview on 19th June 2025 @09:00 AM at THSTI, NCR Biotech Science Cluster, 3rdMilestone, Faridabad-Gurugram Expressway, Faridabad – 121001.
NOTE :
1) The candidates 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.
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