Last Updated on February 14, 2023 by The Health Master
The Translational Health Science and Technology Institute (THSTI) is an autonomous institute of the Department of Biotechnology, Ministry of Science and Technology, Government 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.
Applications are invited from eligible candidates to fill up the following positions.
Consultant Project Manager (01 Positions)
Name of the Study : Digoxin Study
Age Limit : 45 years
Emoluments : Up to Rs. 70,000/-
Duration : 12 months
Location : CDSA, THSTI, NCR, Biotech Science Cluster, Faridabad
Essential qualification and work experience :
• MBBS / BDS / Allied Medical degree OR Ph.D / Master’s degree / diploma in life sciences, pharmacy, public health, healthcare or other related discipline AND A minimum of 2 years’ experience in Clinical Project Management and/or Clinical trial/Study monitoring Post Ph.D. OR
• Masts degree in life science s with 5 years experience in clinical trials / study monitoring
• Experience of clinical trial or public health project management in a recognized organization/institute (academic clinical trials unit, CRO, pharmaceutical, biotechnology, or device company). Desirable qualifications and work experience :
• Postgraduate degree in Public Health
• MD/DNB from a recognized Indian University/ recognized by MCI
• Ph.D. 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.
Job profile
The position is responsible for Responsible for oversight, management and operational execution of assigned clinical studies and trials. Timely delivery of key tasks, while maintaining high quality standards are: –
• The project manager will manage the performance of project team working on projects.
• The management and cross-functional coordination of the project and work closely to develop and maintain the overall project plan and timelines, communicate project expectations to the respective resource/consultant and manage the overall projectbudget.
• Support the team in the implementation of systems for resource planning, study / trial administration, implementation, oversight monitoring, quality assurance and documentation and record keeping
• 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
• Understand the requirements of the various controlling bodies, agencies and frameworks, guiding the project in conforming to those requirements and coordinating any necessary audit processes
• Liaison with Steering Committee and DSMB with a particular view on compliance with Research Governance, Good Clinical Practice, Data Protection and Ethical Requirement
• 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
• Manage distribution, collection and tracking of regulatory documentation to ensure compliance with regulatory and project requirements and audit readiness
• 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
• Faculty for training projects conducted by CDSA
• Any other assignment with Clinical Portfolio Management team, based on project deliverables or exigencies.
Program Manager (01)
Name of the Study : NBM Program
Age Limit : 45 years
Emoluments : Up to Rs. 70,000/-
Duration : one year
Location : CDSA, THSTI, NCR, Biotech Science Cluster, Faridabad
Essential qualification and work experience :
Essential
• MBBS/ BDS/ Alliied Medical degree OR
• Master’s degree/ diploma in life sciences, pharmacy, public health, healthcare or another related discipline. OR
• Postgraduate degree in a health-related discipline
Essential work experience :
• 5 or more years of experience in clinical project management and/or clinical trial/ study monitoring
• Experience of clinical trial or public health project management in a recognized organization/institute (academic clinical trials unit, CRO, pharmaceutical, biotechnology, or device company)
• Candidate with relevant experience in Medical Affairs and/ or Medical monitoring of research projects
• Past experience working on Vaccine projects and/or regulatory studies
• Past experience (at least 2 years) of community-based clinical trials/research shall be an added advantage for the role.
• Demonstrable experience of line management, project management concepts and ability to understand, explain and communicate project concepts using standard tools and templates
Job profile
Responsible to undertake overall coordination of medical review and writing support and cross functional coordination of the programme and work closely with the Project Management unit of National Biopharma mission (NBM) to develop and maintain the overall project plan and time lines. The roles & responsibilities of Medical Monitor (MM) are as follows but not limited to :
• Establishment of procedures to ensure adherence to trial protocols
• Review the study proposal and/or protocol for design, conduct, and develop methods for clinical studies with an emphasis on public health.
• Work with investigators to ensure that the trial is meeting its targets , is producing meaningful output and to predict any changes that warrant requests to changes in protocol , funding or timelines.
• Participates in the development of CRF, statistical analysis plan (SAP), DMC charter, and other documents as required by the study
• Development , approval and distribution of study related documents including case report form(CRF) ,study protocols , study manuals and other study tools to investigational sites and review commitees.
• Literature review to advise PMU on how to modify aspects of the trial without undermining the validity and integrity of the trial for adaptive and seamless designs.
• Scientific review of appropriateness of background and significance of the trial, study design, target population, and risk vs benefit assessment will be done in collaboration with disease-specific expert
• Perform review of data generated by data listings or statistical analyses.
• Assist NBM-PMU for review of interim and final study report.
• Conduct oversight monitoring from a medical perspective. verify the adherence to the procedures outlined in the safety management plans, SOPs, and forms set up for study. Ongoing review of safety data as well as comprehensive safety and medical monitoring during on-site visit.
• Educating, training, and mentoring research teams in safety monitoring and reporting
• Participate in study management team meetings, DMC, and technical review meetings, as per NBM recommendation/ requirement
• Interact with investigative sites, and address protocol/medical questions in consultation with technical experts
• Provide the Study Team with medical expertise during key activities
• Support PMU-NBM to align the constitution of DSMB and compilation of DSMB charter as per study requirements and ensure strict adherence to the DSMB recommendations.
• Work with data management and other departments to track progress and milestones of the project.
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 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 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 forfuture 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 of receipt of online application : 03rd March 2023
The application will be scrutinized/shortlisted and processed for further selection.
SUBMISSION OF APPLICATION WILL BE THRU ONLINE MODE ONLY OTHERWISE IT WILL GET REJECTED OR IGNORED.
Recruitment notice no. : THS-C/RN/01/2023
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