Translational Health Science and Technology Institute (THSTI) is an autonomous Institute of the Department of Biotechnology, Ministry of Science and Technology, Govt. of India. The institute is an integral part of the interdisciplinary NCR Biotech Science Cluster located at Faridabad, and is designed as a dynamic, interactive organization 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 under Clinical Development Services Agency (CDSA) of THSTI. CDSA is a niche centre of THSTI established to facilitate development of affordable healthcare products for public health diseases.
Monthly Emoluments : Up to Rs. 1,65,000/-
Age : 50 Years
Minimum Educational Qualification and Experience : Essential Qualifications and Experience: PhD in Life Sciences/Pharmacy/Healthcare or other related disciplines with at least 8 years of work experience in developing and conducting training programs in health-related topics OR Master’s degree in Life Sciences/Pharmacy/Healthcare or other related disciplines with at least 12 years of work experience in developing and conducting training programs in health-related topics
• Significant experience in directing national and or international programs with various stakeholders.
• Working knowledge of design, development, and execution of high- quality training programs
• Proven competency in developing and coordinating offline as well as online programs with experience in using any eLearning platform.
• Professional knowledge of disbursement of training programs, and feedback analysis
• Demonstrated working experience with LMS, remote proctored examination system, and all automation in the training arena.
• Minimum 8 years of working knowledge in the area of drug development, pre-clinical research, clinical research or clinical development.
• Experience in the design, implementation, monitoring, auditing or management of clinical research/trials.
• Research experience in life sciences, clinical sciences, or pharmacology; experience in initiating scientific/medical education or training programs will be useful.
• In-depth knowledge of local and international guidelines (GCP, GCLP, GCLP; national ethical guidelines) and regulations (NDCT Rules) and quality standards will be preferred
• Professional knowledge on disbursement of training programs.
• Trainer from International/national agencies
• Professional Training on ‘Management of Training’
• Proficient in personnel certification scheme management
A. Leadership and strategy
• Support the CDSA Head in the development of overall strategy
• Develop programs for capacity and capability building in area of clinical development and translational research as per the national mandate and as guided by the Governing Body and Advisory Board
• Lead on drafting relevant training-related policies and standard operating procedures.
• Develop strategies for the design, development, and conduct of high-quality online training programs on a self-sustainable model using platforms like the Learning Management System (LMS).
• Develop strategy for evaluating the training programs and their impact.
• Act on behalf of CDSA-THSTI for training-related activities, meeting with internal and external partners (academic, industry collaborations, vendors, regulators, etc.).
• Ensure consistent application of core CDSA-THSTI policies and operating procedures across the CDSA-sponsored training programs
• Continually review, improve, and respond to all the changes necessary to uplift the quality standards of training programs.
• Implement new and innovative approaches to conduct the training programs
• Provide expert support to training programs at THSTI, and all its collaborators/ stakeholders.
• Participate in workshops to learn about various methodologies and assessment methods related to training thereby contributing to continual improvement.
• With the Head Services, oversee and/ draft Agreements, Memorandums of Understanding (MoUs), or other documents related to the training programs.
• Actively contribute or lead initiatives to the development of CDSA- THSTI in resourcing, skills, training, systems, and aligned activities and strategies.
• Contribute as a resource person in key areas of clinical development like current ethical and regulatory requirements for conducting clinical trials in India, Good Clinical Practice, Good Clinical Laboratory Practice, Good Laboratory Practice, etc., and represent CDSA-THSTI in national & international forums.
• Ensure the dissemination of information for CDSA-THSTI staff on the CDSCO/ ICMR Clinical Trials Regulations and its implications, regulatory requirements, research governance and Good Clinical Practice (GCP).
B. Technical/ Training
• Oversee the development and conduct of training programs that include but are not limited to eLearning programs, Certificate/Diploma courses, webinars, training videos, etc..
• Provide strategic planning for training programs and set program goals and objectives
• Work with various stakeholders to deliver customized training programs
• Contribute to course content
• Oversee the development of handbook, manual, training resource materials, exercises for existing and new courses by liasioning with technical & subject experts and peer reviewers.
• Create awareness about various training programs conducted by CDSA-THSTI across the nation through the website, social platforms, and other outreach avenues.
• Contribute to development of process for trainee and trainer selection for every training program and ensure that the process is followed.
• Steer the training program by leading and motivating the entire crew of trainees and trainers.
• Work towards making the program cost-effective, and professional with unmatched quality and credibility
• Develop and maintain client relationship and endeavour to meet client expectations (internal andexternal)
• Work with national agencies (regulatory, quality), and health/research organizations in co-developing training programs and enhancing the quality outcome
• Oversee the develop of a good database of trainers, institutions, and organizations for the effective conduct of the program.
• Lead on development of process to evaluate the effectiveness of existing training programs
• Analyze and formally report training-related feedback from the trainees, evaluate the effectiveness of training, and convey the feedback to all stakeholders.
• Continually review current training packages and improve program content, delivery methods, and skills through research, feedback, and evaluation.
• Contribute to making the LMS and the online remote proctoring examination system state-of-the art as per the global best practices.
• Lead on the current training program being co-developed with WHO-India and contribute to future online programs of national interest developed by THSTI as a WHO Collaborating Centre on Clinical and Translational Research for Innovation and access to Medical Products.
• Work with other internal departments on their requirements as and when required
• Contribute as a resource person and steer the Master of Science (MSc) in Clinical Research with a specialization in clinical trials program being initiated at CDSA-THSTI in collaboration with THSTI partners and Regional Centre for Biotechnology, Faridabad.
D. GCPPCS scheme management
• Oversee the Good Clinical Practice Professional Certification Scheme (GCPPCS) owned by CDSA-THSTI
• Lead on the technical (GCP) part of GCPPCS and contribute to the certification expertise related to ISO 17024 compliance requirements.
• Lead in Troubleshooting and finding pragmatic solutions when issues or concerns are raised by the team or its users or other stakeholders.
• Ensure GCPPCS awareness is spread across India and beyond borders.
• Support the GCPPCS Secretariat and all Training Institutions, and Personnel Certification Bodies working with CDSA-THSTI.
• Lead training vertical meetings
• Communicate to the CDSA head regarding training needs or performance issues
• Participate in performance evaluation reviews for direct reports
• Contribute to strategic direction of the Trainings group.
• Participate in the recruitment and hiring process.
• Other responsibilities assigned by management
• Monitor financial progress of assigned training programs
• Review budget forecasts and management reports forassigned training programs
• Contribute to budget preparation for training programs and department need
Team Lead- Project Management
Monthly Emoluments : Up to Rs. 1,10,000/-
Age : 45 Years
Minimum Educational Qualification and Experience :
Essential: Medical professional qualification or equivalent (MBBS or BDS or BHMS or BAMS or BPT, etc) OR Master’s degree in Life Sciences OR Pharmacy OR Public Health OR Post graduate degree in a health-related discipline. The candidate should have post qualification experience of at least 5 years in clinical project management and/or clinical trial or public health project management or trial monitoring in a recognized organization/institute (academic clinical trials unit, CRO, pharmaceutical, biotechnology, or device company)
• MD/DNB from a recognized Indian University/ recognized by MCI
• PhD in a health-related discipline
• Demonstrable experience of leading a team
• Experience of line management
• Demonstrable application of project management concepts
• Demonstrated ability to understand, explain and communicate project concepts (project life cycle, scope planning, scheduling, implementation of project plan), and manage project conduct (schedule, quality, and cost control, risk and change management) using standard tools and templates
This position is responsible for the oversight, management and operational execution of assigned clinical studies. Timely delivery of key tasks, while maintain high standards are key responsibility areas. The program manager will also manage the performance of the project teams(s) working on projects under his/her direction. Mentoring and development of project team is a key outcome area for this role. The program manger will serve as point of contact for the sponsors and build sponsor relationships. The program manager is also responsible for working cross functionally and understanding the implications of project management activities on other groups within organization. In addition, this role may also have the responsibility for the project managing clinical/ non-clinical regulatory trial directly. The program lead will have direct line reports like, but not limited to, project managers and CRA’s.
GENERAL TERMS & CONDITIONS
a) For Head Training post the incumbent will be permitted to undertake consultancy services on behalf of the institute and retain a percentage of the consultancy fees as per the Bye-laws of the institute.
b) The positions will be hired initially for a period of one year with a probation period of six months. The 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.
c) All educational, professional and technical qualification should be from a recognized Board/University.
d) The experience requirement specified above shall be the experience acquired after obtaining the minimum educational qualifications specified for the post.
e) Closing date of online application will be the CRUCIAL DATE for determining eligibility with regard to age, essential qualification etc.
f) 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. In case candidates are not found suitable for the posts notified, they can be offered lower post / lower emoluments on the recommendation of the Selection Committee.
g) 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. There is no upper age limit for the Institute employees who are treated as departmental candidates.
h) Age relaxation as per government norms will be provided duly ensuring at least 5 years remaining service for superannuation (60 years).
i) All results will be published on our website and all future communications will be only through email
j) 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.
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 in any form will be a disqualification
HOW TO APPLY
1. 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/MD Degree (if applicable)
viii) Relevant experience certificates (if applicable)
ix) Caste / Disability certificate in the format prescribed by the Govt. of India, if applicable
2. Procedure for filling up online application:
i) The eligible and interested candidates may apply online at the Institute’s website www.thsti.res.in/career. 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:
Unreserved, OBC & EWS candidates : Rs 590/-
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 firstname.lastname@example.org along with the screenshot of the error displayed (if any).
Last date for receipt of online application : 10th June 2022
• THOSE WHO HAVE ALREADY APPLIED IN RESPONSE TO RECRUITMENT NOTICE NO. THS/RN/31/2021, THS/RN/45/2021 & THS/RN/03/2022 NEED
NOT TO APPLY AGAIN.
• The applications will be scrutinised/shortlisted and processed for further selection.
Recruitment Notice No. THS/RN/18/2022
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