Opportunity for M.Pharm or M.Sc as Program Manager at CDSA - Pay Up to Rs. 90,000 pm

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.

Post : Program Manager (01)

Name of the Program : NBM Program

Emoluments : Up to Rs. 90,000/-

Age Limit : 45 Years

Duration : One year

Location : CDSA, THSTI, NCR, Biotech Science Cluster, Faridabad

Minimum Educational Qualification and 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.

Professional Skills
• Ability to gain trust and confidence with stakeholders.
• Operational skills including focus and commitment to quality management and problem-solving
• Influencing skills including negotiation and teamwork
• Effective communication skills, the provision of timely and accurate information to stakeholders
• Understanding and applied knowledge of GCP, clinical trial regulations, and ICMR guidelines on ethical standards for biomedical health research
• Knowledge of adverse medical event investigation, analysis, and reporting procedures and standards
• Fair and ethical. Creates a culture that fosters high standards of ethics.
• Basic business computer skills (MS Word, Excel, e-mail)

GENERAL TERMS & CONDITIONS
a) The position is short-term basis with a probation period of three months. The extension will be granted subject to the 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.
d) Closing date of online application will be the CRUCIAL DATE for determining eligibility with regard to age, essential qualification etc.
e) The 05 number of positions to be hired, 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.
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. There is no upper age limit for the Institute employees who are treated as departmental candidates. g) All results will be published on our website and all future communications will be only through email
• Understanding and applied knowledge of GCP, clinical trial regulations, and ICMR guidelines on ethical standards for biomedical health research
• Knowledge of adverse medical event investigation, analysis, and reporting procedures and standards
• Fair and ethical. Creates a culture that fosters high standards of ethics.
• Basic business computer skills (MS Word, Excel, e-mail)
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) With regard to any provisions not covered in this notification, the bye laws of THSTI / Govt. ofIndia rules / guidelines shall prevail. j) Canvassing wrong in any form will be a disqualification. k) The candidate may be transfer to site location as per the project requirement and management discretion

HOW TO APPLY
1. Documents to be kept handy before filling up the online application: (all the documentsexcept (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 https://thsti.res.in/en/Jobs. 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.

Last date of receipt of online application : 26TH May 2023
The application will be scrutinized/shortlisted and processed for further selection.