Post Graduate Degree Professional Require in Clinical Portfolio Management at CDSA

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.

Post : Chief – Clinical Portfolio Management

No of Post : 01
Emoluments : Rs. 2,11,200/-
Age : 55 Years

Essential qualification and work experience :
• Medical professional qualification (MBBS OR BDS or equivalent qualification)from a recognized university with at least 12 years of work experience in clinical project management and/or drug development. OR
• Post graduate degree in a Science or health related discipline with at least 15 years of work experience in clinical project management & monitoring and/or drug development. AND
• Significant experience of clinical trial or public health project management in a recognized organization /institute (academic clinical trials unit, CRO, pharmaceutical, biotechnology, or device company) leading/directing a clinical study / R&D team.

Job profile
Lead the clinical trial/studies operations function at CDSA, with overall responsibility for portfolio oversight, project management quality monitoring and clinical operations. The role requires deep expertise in national and global clinical research regulations, experience in regulatory trials, and the ability to build and oversee systems that ensure high-quality, compliant, and efficient trial conduct
A. Leadership and Strategy
• Support the Faculty-In-Charge in shaping CDSA’s clinical research strategy and portfolio
• Lead development and implementation of policies, SOPs, and systems for clinical trial/study conduct and reporting
• Establish and oversee frameworks for portfolio prioritization, cost recovery, and sustainable program growth
• Ensure alignment with CDSCO, ICMR, GCP, and international regulatory requirements
• Provide strategic oversight on compliance, sponsorship responsibilities, and high-risk or complex studies
• Represent CDSA in interactions with regulators, sponsors, and external partners, including during inspections and audits
• Lead change management in response to evolving regulatory and research environments
• Contribute to institutional development, including capacity building, resourcing, and capability strengthening
• Support development of MoUs and contractual frameworks in coordination with administrative and legal teams.

B. Clinical Operations and Portfolio Oversight
• Oversee end-to-end management of clinical trials/studies across the CDSA portfolio
• Provide oversight of project planning, budgeting, timelines, resource allocation, and deliverables
• Ensure robust study start-up processes, including feasibility, contracts, regulatory and ethics submissions
• Review and provide strategic input into protocols, regulatory documents, and study reports
• Ensure adherence to SOPs, regulatory requirements, and quality standards across all projects
• Monitor portfolio performance through defined metrics and implement corrective actions where needed
• Lead troubleshooting and resolution of operational challenges across studies
• Support business development, proposal development, and sponsor engagement

C. Quality Oversight and Monitoring
• Strengthen technical capacity within the operations team in modern monitoring approaches, including mentoring staff and embedding quality-by-design principles from protocol development through study start-up
• Lead the development and implementation of central statistical monitoring (CSM) within CDSA’s monitoring framework, aligned with risk- based monitoring strategies
• Ensure implementation of risk-based quality management systems across studies, including definition and tracking of key risk indicators and quality tolerance limits
• Oversee the design and execution of monitoring plans aligned with participant safety and data integrity risks
• Provide oversight of site performance and monitoring activities, including on-site and centralized approaches as appropriate
• Ensure inspection readiness and compliance with regulatory, GCP, and audit requirements

D. Stakeholder Engagement and Communication
• Serve as a key point of contact for sponsors, investigators, regulators, and collaborators
• Oversee communication of project scope, timelines, risks, and performance to stakeholders
• Ensure effective coordination across multidisciplinary teams
• Oversee reporting of study progress, safety, and performance metrics

E. Training
• Lead training initiatives in clinical research operations, GCP, and regulatory requirements.
• Mentor and build capacity within the Clinical Portfolio Management team
• Contribute as faculty to CDSA training programs

Skills / Knowledge / Aptitude
• Strong leadership and program management capabilities, with experience in managing complex clinical trial portfolios
• In-depth understanding of CDSCO, ICMR, GCP, and international regulatory frameworks
• Demonstrated experience in regulatory trials and sponsor oversight responsibilities
• Strategic thinking with strong problem-solving and decision-making abilities
• Excellent communication and stakeholder management skills
• Ability to work across academia, industry, and regulatory interfaces
• High level of integrity, accountability, and attention to detail
• Proficiency in standard digital and project management tools
• Willingness to travel as required

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

HOW TO APPLY
Documents to be kept handy before filling up the online application : (all the documents except
(i) should be in pdf format):
i) A soft copy of your passport size photo and signature. (jpeg/jpg/png format)
ii) A comprehensive CV containing details of qualification, positions held, professional experience / distinctions etc.
iii) Matriculation certificate (equivalent to 10th Standard) / Mark sheet
iv) Intermediate certificate (equivalent to 12th Standard) / Mark sheet
v) Graduation/Diploma degree certificate / Mark sheet
vi) Post-Graduation degree certificate & Mark sheet (if applicable)
vii) PhD degree/certificate (if applicable)
viii) Relevant experience certificates (if applicable)
ix) Caste / Disability certificate in the format prescribed by the Govt. of India, if applicable

Procedure for filling up online application :
i) The eligible and interested candidates may apply online at the Institute’s website. Applications
through any other mode will not be accepted.
ii) The following will be the step wise procedure-
A) Step 1 : Details of applicant
B) Step 2 : Uploading of documents
C) Step 3 : Payment of application fee
• The payment can be made by using Debit Card / Credit Card / Internet Banking/ UPI.
• Once payment is made, no correction / modification is possible
• Candidates are requested to keep a copy of the provisional receipt for future reference.
• Fee once paid shall not be refunded under any circumstances.
• Details of fees to be paid are as shown below :
1. Unreserved, OBC & EWS candidates : Rs. 590/-
2. SC/ST/Women/PwBD : Rs 118/-
D) Step 4 : Submission of application form
iii) On successful submission of application, an auto-generated email containing the reference number will be sent to the email address provided. Please keep a note of the reference number for future correspondence.
iv) Candidates are required to keep a printout of the online application form by using the print button on the dashboard for future reference.
v) Candidates must ensure that he / she fulfils all the eligibility criteria as stipulated in the advertisement. If it is found that he / she does not fulfil the stipulated criteria during the recruitment process, the candidature of the candidate will be cancelled. If the same is noticed after the appointment, the candidate will be terminated following due process.
vi) Incomplete applications shall be summarily rejected and no correspondence in this regard shall be entertained.
vii) In case of difficulty in filling up the online form, please send e-mail to personnel@thsti.res.in along with the screenshot of the error displayed (if any).

Last date for receipt of online application : 10th April 2026
The applications will be scrutinised / shortlisted and processed for further selection.

RECRUITMENT NOTICE NO.: THS-C/RN/05/2026