Program Manager

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About the Organization

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.

Job Description

The Program 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

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.

Education Qualification/Required Skills & 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 fastpaced 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.

Salary

Rs. 67,000/- + 18% HRA = Rs. 79,060/-

For more information please check the Link

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