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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. यह भर्ती क्लिनिकल डेवलपमेंट सर्वसि ेज एजेंसी (CDSA) कें द्र में परियोजना पदों की रिक्तियों को भरन े के लिए की जा रही है। CDSA, THSTI का एक विशेष कें द्र है, जिस े सार्जव निक स्वास्थ्य रोगों के लिए किफायती स्वास्थ्य उत्पादों के विकास को सुविधाजनक बनान े के उद्देश्य से स्थापित किया गया है। यह देश का एकमात्र सार्जव निक कें द्र है जिसे लाभ-न कमाने वाल े तकनीक-आधारित प्रीक्लिनिकल और क्लिनिकल उत्पाद विकास के साथ-साथ सार्जव निक एजेंसियों द्वारा किए जाने वाल े क्लिनिकल अनुसंधान को समर्नथ और पोषण देने के उद्देश्य से बनाया गया है। यह प्रशिक्षण और सीखन े के एक इको-सिस्टम के विकास की दिशा में काम करता है और सार्जव निक क्षेत्र की सस्ं थाओं तथा छोटे और मध्यम उद्यमों (SME) के साथ मिलकर नवाचारपूर् ण तकनीकों को जनहित में चिकित्सीय उत्पादों में बदलने का कार् य करता है। This recruitment is to fill up the vacancies for project positions at Clinical Development Services Agency (CDSA) center. CDSA is a niche center of THSTI established to facilitate development of affordable healthcare products for public health diseases. It is the only public Centre in the country created with a mandate to support and nurture cost-effective, high quality, not-for-profit technology-based preclinical and clinical product development as well as support clinical research conducted by public agencies. It works towards development of an eco-system for training and learning and work with public sector institutions, and small and medium enterprises (SME) to translate innovative technologies into medical products for public good. CDSA के मुख्य उद्देश्य निम्नलिखित हैं: a. एक अकादमिक क्लिनिकल रिसर् च यूनिट के रूप में, अध्ययन योजना, सेटअप, सचं ालन, परियोजना प्रबंधन, निगरानी, डेटा प्रबंधन, सुरक्षा रिपोर्टिंग, विश्लेषण और रिपोर्ट लेखन में अन्वेषकों और SMEs को अंत-to-अंत क्लिनिकल अध्ययन समर्नथ प्रदान करना। b. क्लिनिकल विकास/प्रयोजन और नियमन के क्षेत्र में उच्च गुणवत्ता वाल े प्रशिक्षण के माध्यम से शोध क्षमता और क्षमता का निर्मणा करना। c. देश में क्लिनिकल रिसर् च पर्यावरण का समर्नथ और सुदृढ़ करना। d. नियामक विज्ञान और नीति समर्नथ : शोधकर्ताओ,ं नियामकों, स्वास्थ्य नीति निर्माताओं और उद्योग को समर्नथ देने के लिए उपकरण और दृष्टिकोण प्रदान करना। The main objectives of CDSA are: a. As an academic Clinical Research Unit, to undertake & provide end -to- end clinical study support for investigators and SMEs in study planning, set up, conduct: project management, monitoring, data management, safety reporting, analysis and report writing b. Build research capacity and capability through high quality training in the area of clinical development/trials and regulation c. Support and strengthen clinical research environment in the country d. Regulatory science and policy support: provide tools and approaches to support researchers, regulators, health policy makers & industry. 4. यह भर्ती निम्नलिखित परियोजनाओं के तहत ब्रिक-टीएचएसटीआई की रिक्तियों को भरने के लिए है: This recruitment is to fill up the vacancies of BRIC-THSTI under the following projects:

पद के लिए आवश्यक शैक्षिक योग्यता और अनुभव /Educational Qualification and Experience required for the post: 1. पद का नाम/Name of डाटा प्रबंधक/ Data Manager the post पदों की संख्या/Number 01 of the post /Name Sepsis related mortality in neonates in India: A multi-disciplinary, multi- परियोजना का नाम institutional research program for context specific solutions of the Project /Emoluments Rs. 56,000/- + HRA वेतन /Age Up to 35 years उम्र Essential qualification and work experience: न्यनू तम शक्षै िक योग्यता और अनभु व /Minimum • Master’s degree in any field preferably in science, with 6 years of experience Educational in clinical data management/clinical research/operations/MIS/data analysis/IT/computer science/healthcare field Qualification and OR Experience • Graduation degree in any field preferably in science, with 8 years of experience in clinical data management/clinical research/operations/MIS/data analysis/IT/computer science/healthcare field Desirable qualification and work experience: • Diploma in Clinical research and clinical data management. Familiarity with industry standard CDMS and some programming skills: • Preparation of Clinical Study Data Management documents. • Clinical Study Protocol understanding and experience in the preparation of नौकरी का प्रोफ़ाइल/ Data Management documents - DMP (Data Management Plan), DVP (Data Job profile Validation Plan/ Edit Checks Document), Annotated CRF, Data Entry Guideline etc. • Quality Check of Database Design, Validation Program, Annotated CRF, Data Extract Views, Laboratory Details, Site and Investigators and Final Data Listings • Good experience and working knowledge of CRF designing • Preparation of Data transfer guidelines for external data load and self- evident correction chart. • Working knowledge of Query management, data cleaning, data freezing and data archival. • Change Requests and takes approval from sponsor • Global library review and approval for changes • Interact with other project team members to support the set-up, maintenance, and closure of the Data Management aspects of the project • Sound knowledge of Clinical Database Development tools, logics and techniques and GCDMP • Working knowledge of database standards and study development process, CDM SOPs, CDISC & SDTM standards • E/SAE reconciliation • Knowledge of medical dictionaries integration and medical coding in the databases. • Preparing interim reports and review of listings of data for clinical trial status and data extraction in collaboration with the statistician

• Maintaining and archiving of clinical study related documents • Participates in cross functional team meetings & external client meetings as DM representative • Generate ad-hoc reports as needed • The data manager will ensure that security of all data is maintained and confidentiality of participants is protected. • Managing requests for data from external third parties – including liaising with internal staff and external collaborators to provide data in a timely and appropriate manner and maintenance of a database detailing the status of such external data requests. • Knowledge of Laboratory Information Management Systems (LIMS) to track requisition and specimen status to ensure prompt turnaround time of sample results. • Maintain stringent standards for quality, identifying any issues which might adversely impact the quality of test results and immediately communicating these to the appropriate management representatives to ensure prompt resolution • Create charts, graphs, dashboards, and other visual representations to present data • Coordinate the archiving of study databases and related documents • Effective interaction with intra-departments to ensure all required, vital information and documentation is acquired in a timely manner. • Lead in preparation of datasets for analysis including data cleaning and ensuring compliance with the data protection. • Develop Standard Operation Procedures and train study staff • Supervise DM activities at the clinical site. /Skills • Good management & leadership skills कौशल • IT literate (experience with Microsoft based applications, data visualization and other CDMS applications) • Must have experience in handling databases and query management • Client focused approach to work • Meticulous attention to detail. • Must have understanding of clinical trials and familiarity with clinical data management functions. • Good interpersonal, verbal and written communication skills. • Client focused approach to work. • A flexible attitude with respect to work assignments and new learning. • Meticulous attention to detail. • Effective time management in order to meet metrics or team objectives. • Commitment to project and team goals. • Must be able to work independently but seek guidance when necessary. • Team player with outstanding inter-personal, negotiation skills and organizational skills. • Sense of urgency in completing assigned tasks. • Exhibits a sense of urgency about solving problems and completing work. • Shows commitment to and performs consistently high quality work. • Ability to model behaviors and ethics in line with CDSA Mission and Vision 17 November 2026 @09:00 AM at THSTI, NCR Biotech Science Cluster, वॉक-इन साक्षात्कार की तिथि/ 3rd Milestone, Faridabad-Gurugram Expressway, Faridabad – 121001 Date of walk-in interview:

2. पद का नाम/Name of परियोजना अनुसंधान वैज्ञानिक – I (गैर-चिकित्सीय) /Project Research Scientist - I (Non-Medical) the post 01 पदों की सख्ं या/Number of the post Sepsis related mortality in neonates in India: A multi-disciplinary, multi- परियोजना का नाम/ institutional research program for context specific solutions Name of the Project Rs. 56,000/- + HRA वेतन/Emoluments Up to 35 years उम्र/Age Essential Qualification: न्यनू तम शक्षै िक योग्यता • Post Graduate Degree, including the integrated PG degrees और अनुभव/Minimum Educational Desirable Qualification and Experience: • Postgraduate degree in Clinical Research, Clinical Trials, Epidemiology, Public Qualification and Health, or a related discipline from a recognised university Experience • Additional qualification or prior training in Medical Laboratory Technology or a related laboratory discipline. • Experience in clinical research, preferably involving biological sample collection, processing, storage, transport, and associated documentation. • Experience in preparing standard operating procedures (SOPs), study workplans, and coordinating study activities. • Good Clinical Practice (GCP) certification. • Support the coordination and management of clinical studies, including नौकरी का प्रोफ़ाइल/ ethics and institutional approvals. Job profile • Monitor study related laboratory processes including sample collection, processing, labeling, storage, transport, tracking, testing workflow, and documentation, to ensure compliance with protocol requirements, SOPs, and applicable quality standards, including GCLP principles, where applicable. • Develop, review and maintain trial documents, including protocols, SOPs, CRFs, trial manuals, and operational guidelines. • Support trial close-out activities, including database lock, site close-out, reconciliation and archiving of essential trial documents, and completion of trial close-out requirements. • Coordinate the transfer, storage, or destruction of trial materials and biological samples in accordance with the trial protocol and applicable guidelines. • Contribute to scientific writing, including manuscripts, trial protocols, grant reports, and conference presentations. • Ensure adherence to the protocol, ethical requirements, and applicable guidelines, and support identification and escalation of protocol deviations and site-level issues • Conduct site monitoring visits from site initiation through closeout, ensuring trials are conducted in compliance with the study protocol, GCP guidelines, SOPs, and applicable regulatory requirements. • Coordinate with investigators, collaborators, and external stakeholders to ensure effective study execution • Provide training and operational guidance to study teams on protocol, processes, and documentation requirements, as applicable

• Perform any other project related duties assigned by the Principal Investigator. /Skills • Proficient in computer literacy in Excel, ...

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