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.
Quality Manager
Number of the post : 01
Name of the Project : Improving maternal and neonatal outcomes using imaging data science
Emoluments : Rs. 56,000/- + HRA
Age : Up to 35 years
Minimum Educational Qualification and Experience
Essential qualifications and work experience :
• Post Graduate Degree, including the integrated PG degrees.
Desirable : The candidate must possess a valid GCP certificate.
• Two (2) years of work experience as a Clinical Research Associate/ Clinical Research Coordinator/ Site Manager in Clinical Research.
Job profile
• The Quality Manager is responsible for the oversight, management and operational execution of assigned clinical studies and trials under the supervision of the Project Manager and the Chief-CPM.
• The Quality Manager must ensure the integrity of the trial by monitoring data, processes, and documentation both onsite and remotely.
• Ensure high-quality standards on delivery of key tasks with adherence to project timelines and deliverables.
• Conducting site qualification, initiation, monitoring, and close-out visits for designated clinical trial and willing to travel to all clinical sites across India on short notice, and stay for extended periods as required.
• Understand the requirements and frameworks of the various regulatory bodies such as DBT, ICMR, HMSC etc, and guide the project conforming to those requirements.
• Responsible for the establishment of quality assurance procedures and time points across various aspects of the overall project functioning.
• Prepare a risk assessment and mitigation plan for the study and, ensure its implementation.
• 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.
• 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 (CRF’s), study protocols, study manuals, and other study tools to investigational sites and review committees.
• 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 update.
• Provide guidance and operational area training for project team members and staff as required
• Responsible for the training, task allocation and evaluation of the performance of the study monitors.
• Any other assignments with the Clinical Portfolio Management team, based on project deliverable or exigencies.
Skills
• Ability to work independently with minimal guidance as well as collaboratively within a team setting.
• Leadership skills that include the ability to build effective project teams, ability to motivate others, delegate, drive and timely/quality decision- making
• Business/ Operational skills that include a commitment to quality management and problem-solving.
• Effective communication skills that ensure the provision of timely and accurate information to stakeholders. Proficient in English, Strong written and oral communication skills.
• Proficient in computer literacy in Excel, Word, PowerPoint, and Access.
• Good writing skills, including the ability to develop and deliver presentations, prepare technical reports, manuscripts, monitoring plans and SOPs.
• Comprehensive understanding of Indian Clinical Trials Regulations, ICH and CDSCO Good Clinical Practice
• Knowledge of regulations and guidelines pertaining to the conduct of clinical trials/ studies on human subjects.
• Personal qualities that include the ability to gain trust and confidence with a variety of clients, good learning ability, managerial courage, ability to prioritize workload, action-oriented and flexible to accommodate in changing environment.
• Influencing skills including negotiation and teamwork.
Senior Project Associate
Number of the post : 01
Name of the Project : INDIGO Effective and Affordable flu Vaccine for the world
Emoluments : Rs. 42,000/- + HRA
Age : Up to 40 years
Minimum Educational Qualification and Experience
B.Tech/ M.Sc./ M.Tech degree or two years PG Diploma in Clinical Research / Clinical Research Management / Regulatory Affairs / Life Sciences or related field from a recognized University, with atleast four (4) years’ experience in clinical trial site coordination,clinical trial/site management, and clinical trial monitoring.
Job profile
The Senior Project Associate plays a pivotal role in supporting the execution and management of clinical trials across all stages. Working under the direction of the Project Manager and study monitors, they ensure the smooth operation of daily trial activities, maintain regulatory and trial documentation, and coordinate communication and logistics across study stakeholders. This role is expected to work independently on assigned tasks, proactively identify potential issues, and propose process improvements.
Key Responsibilities :
Clinical Trial Support & Documentation
• Coordinate and track the distribution and reconciliation of clinical trial supplies, laboratory kits, and investigational products to investigational sites.
• Ensure timely delivery and tracking of essential study documents and materials in accordance with study timelines and site activation plans.
• Maintain and regularly update trial tracking tools (e.g., enrollment logs, regulatory document trackers, training logs).
Regulatory & Site Start-up Support
• Support CRAs and site staff in the collection, review, and tracking of essential regulatory documents for ethics committee and regulatory authority submissions.
• Assist in preparing site initiation packages and supporting site readiness for activation.
• Liaise with regulatory, legal, and contracts departments to ensure timely processing of site contracts and confidentiality agreements.
Trial Master File (TMF) Oversight
• Lead TMF set-up and ongoing maintenance, ensuring completeness, accuracy, and audit-readiness of clinical documentation.
• Perform periodic TMF quality control (QC) checks and contribute to TMF metrics and reconciliation activities.
• Support the development and implementation of TMF filing plans and oversight reports. Meeting Coordination & Communication
• Schedule, coordinate, and document clinical team meetings, site communications, and teleconferences; maintain meeting agendas and minutes.
• Assist with the organization and execution of investigator meetings, including logistics, preparation of materials, and follow-up documentation.
Data & Site Management
• Support CRAs with clinical data flow, Case Report Form (CRF) tracking, and resolution of data queries with investigational sites.
• May accompany CRAs on monitoring visits to gain on-site experience and provide additional support during critical phases of the trial.
Cross-functional & Operational Support
• Serve as the central point of contact for the clinical team regarding project- specific communications and documentation.
• Collaborate with Clinical Portfolio Management, Regulatory Affairs, Data Management, and Quality Assurance to ensure alignment of deliverables.
• Support budget tracking, invoice verification, and financial documentation coordination related to trial expenses and vendor contracts.
Quality & Compliance
• Ensure adherence to ICH-GCP, applicable regulatory requirements, and internal Standard Operating Procedures (SOPs).
• Participate in internal and external audits and inspections as needed; support audit readiness and CAPA (Corrective and Preventive Action) implementation.
• Contribute to internal quality initiatives and process optimization efforts.
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) 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/Department 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.
f) All results/notifications will only be published on our website. Therefore, the candidates should essentially visit THSTI website, regularly.
g) All communications will only be made through email.
h) 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.
i) The no. of vacancy indicated above may change subjected to the actual requirement at the time of Written test/skill test/interview.
j) With regard to any provisions not covered in this notification, the bye laws of THSTI / Govt. of India rules/ guidelines shall prevail.
k) Canvassing wrong information in any form will be a disqualification.
NOTE :
1) The candidates applying for the above mentioned post 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.
Walk in Interview
Quality Manager : 11th September 2026 ; 9:00 AM
Senior Project Associate : 13th September 2026 ; 09:00 AM
at THSTI, NCR Biotech Science Cluster, 3rd Milestone, Faridabad-Gurugram Expressway, Faridabad – 121001
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