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.
Administrator- Training
Number of posts : One Post
Emoluments : Up to Rs 1,10,000/- Age: 45 years
Minimum Educational Qualification and Experience
Master’s degree in Life Sciences/ Pharmacy/ Healthcare/ IT/ Education or other related disciplines with 5 years of proven experience in developing and coordinating training programs.
OR
Bachelor’s degree in Life Sciences / Pharmacy / Healthcare/ IT or other related disciplines with 8 years of proven experience in developing and coordinating training programs
Job profile : This position is responsible for developing, management and operational execution of assigned training programs. Timely delivery of key tasks, while maintaining high quality standards are key responsibility areas. The training manager will also manage the performance of the training team(s) working on programs under his/her direction. Mentoring and development of the training team is a key outcome area for this role. The training manager will serve as a point of contact for the sponsors and build sponsor relationships. The training manager will have direct line reports like, but not limited to, training coordinator, etc. Administrator- Training will have responsibilities that support both department’s vision and purpose. She/he will be working in close coordination with Head Training in meeting various new initiatives and existing programs.
Research Scientist (Bioinformatics)
Number of posts : One Post
Emoluments : Up to Rs 1,10,000/-
Age : 40 years
Minimum Educational Qualification and Experience
MD or MVSc or M.Tech with minimum 2 years’ relevant post qualification research experience
PhD in Life Sciences / Computational Science/ Bioinformatics / Genomics from a recognized University with minimum 6 months relevant post qualification research experience.
Job profile
Research and support to the ongoing Big data analysis or next generation DNA sequencing data analysis or Proteomics and metabolomics data analysis.
Training Coordinator
Number of posts : One post
Emoluments : Up to Rs 66,000 /-
Age : 30 years
Minimum Educational Qualification and Experience
Bachelors in Human Resource Management / Life Sciences / Pharmacy / IT / Healthcare or other related disciplines with at least 3 years of working knowledge in coordinating training programs
Graduate in any discipline with at least 5 years of working knowledge in coordinating training programs.
Job profile
CDSA’s Training Coordinator will have responsibilities that support both department’s vision and purpose. She/he will be working in close coordination with Head Training and Training Manager in meeting various new initiatives and existing programs. She/he will report to Training Manager.
Chief- Clinical Portfolio Management
Number of posts : One
Emoluments : Up to Rs 2,11,200/- Age: 55 years
Minimum Educational Qualification and 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 and/or drug development.
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 conduct team with overall responsibility for project management including quality monitoring and clinical operations for clinical studies.
A. Leadership and Strategy
• Support the CDSA Head in the development of overall strategy Lead on drafting relevant policies and standard operating procedures Contribute to developing the clinical trials/studies portfolio
• Lead on the development of systems/processes for conduct and reporting on clinical trials / studies and medical device portfolio (including mechanisms for prioritizing clinical trials/ studies and for ensuring full cost recovery and income generation).
• Analyze and formally report data and information on trends related to research sponsorship activities
• Ensure consistent application of core CDSA policies and operating procedures across the CDSA sponsored trials/ studies portfolio
• Act as the lead on behalf of CDSA for projects and committees, meeting with internal and external partners (academic and industry collaborations, vendors, sponsors and manufacturers and regulators)
• Continually review and respond to changes required to shape the infrastructure, functionality and standards of clinical trials/ studies management, including the development and implementation of systems, operating procedures and policies.
• Effect change and/or ensure dissemination of regulatory effective change management systems are implemented to facilitate the changing clinical trials environment in India and CDSA, in particular the operational implications of new clinical trials and CDSCO/
• ICMR regulations and policies.
• Provide expert support to projects with regards to compliance, policy, sponsorship and high-risk studies
• Represent CDSA at regulatory inspections and meetings as required
• Act as a key advisor on, collating project reports and writing position papers as well as advising on “higher risk” studies
• With the Administrative Manager and Head Regulatory Science and Medical Affairs, oversee and draft Memorandum’s of Understanding (MoU’s) or other documents to outline the delegation of duties from the sponsor office to CDSA and other stakeholders of the projects Actively contribute to or lead on initiatives related to the development of CDSA including resourcing, skills and training, systems and aligned risk assessments and strategies
• Lead in trouble shooting and finding solutions when issues or concerns are raised by researchers with regards to trials and “higher” risk studies
• Ensure the dissemination of information for CDSA staff on the CDSCO/ ICMR Clinical Trials Regulation and its implications, regulatory requirements, research governance and Good Clinical Practice (GCP).
B. Operations Management
• Oversee the preparation of proposals Participate in business development activities.
• Participate in clinical review meetings (teleconferences and /or face to face) and document preparation for meetings as required
• Solicit expert advice, develop collaborative relationship with key experts and investigators Organize meeting with investigators to understand the scope of work Ensure that any relevant Master Services agreement is in place for individual projects Review the Project contract with appropriate functional heads to identify staff necessary for the project team
• Oversee and ensure implementation of project plan, including all elements listed in the project plan template as appropriate for project (Roles & Responsibilities, Communication Plan, Risk Analysis etc.)
• Oversee preparation of initial budget for the project Review and provide input for responses to IEC and regulatory agencies Responsible for reviewing study protocols, investigator's brochure, clinical study reports, IND sections
• Revise SOPs or suggest process improvements for consideration.
• May draft new SOPs for review and act as reviewer for Clinical SOPs, as assigned and appropriate.
• Provide input as necessary to Feasibility Studies, Data Safety Monitoring Committee (DSMC) and other committees, clinical/ product development planning meetings Provide or arrange for project-related training as needed for team members Initiate the project following Best Practices in Project Management
• Ensure the project is progressing according to quality standards, SOPs, regulations, and guidelines
• Use project plan as a management tool to record and measure progress, updating as necessary
• Track resources and actual time spent on each project task for all team members to evaluate project progress and profitability
• Review metrics reports regularly and follow through on actions required Determine the cause of project overruns, recommend and institute corrective action, with input from functional Primaries
• Attend and represent project management/ contracted services at internal meetings and investigator meetings
• Ensure information entered into management system is accurate, and updated on a regular basis
• Ensure the project is completed within the budget, schedule, and according to contract specifications
• Provide consulting services to assist in the development of new drugs or devices under the direction ofthe Head of Organization.
C. Quality Monitoring
• Work with investigators prior to start of project on incorporation of quality management processes into the scientific and operational design ofthe trial
• Develop a monitoring plan with project investigators that is tailored to the specific human subject protection and data integrity risks ofthe trial
• Agree predefined quality tolerance limits to identify systematic issues that can impact
participant safety or reliability of trial results
Be responsible for leading the contracted projects or oversee the studies whenever a designated project lead is assigned to a study.
Oversight for quality monitoring as per the approved plans.
Visit sites and participating institutes as and when required.
D. Communications
• Serve as primary contact for the project
• Communicate to team members the scope of work, timeline and project goals, technical information, and input from client throughout the project
• Inform team members of any new information or modification of project-related issues which may affect specific responsibilities of team members
• Work with appropriate Managers on any anticipated need for addition or re-assignment of resources
• Communicating with study investigators for evaluation of status of participant recruitment and progress to study timelines; supporting safety reporting and IEC submissions; maintaining and reporting metrics for clinical site performance
• Provide Line Manager with input regarding team members’ performance as needed for employees’ periodic Performance Review
• Prepare administrative reports and submit to clients as required by the contract exhibit, and other resource reports
• Communicate fiscal, contractual, resource, deliverable and client- related issues to HoD as appropriate.
E. Training
• Develop project specific and protocol specific training
• Provide guidance and operational area training for project team members and staff as required
• Act as mentor for CPM staff and oversight for their training and development.
• Faculty for training programs conducted by CDSA.
Head Regulatory Science and Medical Affairs
Number of posts : One Post
Emoluments : Up to Rs 1,65,000/-
Age : 55 years
Minimum Educational Qualification and Experience
Medical professional qualification (MD OR MBBS or equivalent qualification) from a recognized university with at least 10 years of work experience in clinical research especially in clinical operations (start- up activities), regulatory function, medical affairs including medical monitoring, medical writing, pharmacovigilance and medical coding and systems for adverse event review and reporting, safety reporting and management.
Job profile
Lead the medical and regulatory aspects of clinical trial/studies. Overall responsibility to lead the team on development of protocol, study design, regulatory pathway, medical affairs and safety reporting.
Serve as medical liaison to all stakeholders - funding agencies, investigators, project teams. Leadership and Strategy:
• Provide leadership on medical and regulatory aspects of clinical trials and clinical study projects.
• Participate in business development activities
• Contribute to drafting policies and standard operating procedures
• Contribute to developing the clinical trials / studies portfolio
• Act as a key advisor on regulatory matters, and writing position papers as well as advising on “higher risk” studies.
• Responsible for dissemination of information for CDSA staff on all CDSCO/ ICMR Clinical Trials Regulation and its implications, regulatory requitrements, research governance and Good Clinical Practice (GCP)
• Serve as a liaison for medical and regulatory functions to all stakeholders - funding agencies, sponsor, investigators, project teams and provides medical and regulatory guidance throughout the life cycle of trials/studies.
• Provide guidance and oversees safety management, medical monitoring/coding and medical writing functions.
• Responsible for start-up activities inclusive of regulatory submission dossiers, wherever applicable, and managing the regulatory compliance of the clinical studies.
• With the Administrative Manager and Chief of Clinical Portfolio Management, oversee and draft Memorandum’s of Understanding (MoU’s) or other documents to outline the delegation of duties from the sponsor office to CDSA and other stakeholders of the projects
Medical Affairs (50%)
• Provide leadership to clinical trial and clinical study projects on medical and safety aspects.
• Participate in clinical review meetings and document preparation for meetings as required
• Guide the project teams in the preparation and review of study documents like oclinical protocols, informed consent forms etc.
ointegrated clinical and statistical summary reports, o meeting presentations otherapeutic area training material ojournal articles, and other documents
• Review all documents assigned for scientific/ medically relevant issues including drug safety
• Review and sign off technical documents written with respect to medically relevant matters with particular attention to those relating to drug safety
• DSMB: Develop/ review DSMB charter, support constitution of DSMB for clinical trials, organize and coordinate DSMB meetings
• Provide input as necessary to Feasibility Studies, Data and Safety Monitoring Committees (DSMC) and other committees, clinical/ product development planning meetings
• Act as medical liaison with clients and solicit expert advice, develop collaborative relationship with key experts and investigators
• Assist in the preparation of client proposals
• Oversee the medical monitoring and medical coding function for all the clinical studies in which CDSA is involved.
• Train/mentor and provide leadership to the medical monitor(s) and coders assigned to the clinical studies/trials
• Oversee and ensure accurate interpretation of single and or grouped adverse events, serious adverse events, drug effect and attribution of causality, and disease condition
• Oversight / review of clinical narrative reports prepared by the Investigators describing the event; advise on individual participant cases as identified by the study team and identifying queries for the local monitors to complete.
• Ensure compliance with clinical safety and good pharmacovigilance practices and requirements
• Review and provide support in finalizing Periodic Safety Update Reports (PSURs)
• Review and edit CSR for clinical consistency with data and standard of practice
• Review and sign off Data Management listings of safety data (including adverse events, laboratory data, vital signs data, medical history, physical examination, concomitant medication),
• Assist the PI and DSM in establishing the presence or absence of clinically meaningful trends and, if noted, assisting in follow up as appropriate with the project team, sponsor, and Regulatory Authorities
• Review and provide input for AEs (coded), past medical history, concomitant medications or other medical data listings to verify and medically vet clinical data.
• Provide consulting services to assist in the development of new drugs or devices under the direction of the Head of Organization
Regulatory Science (40%)
• Act as regulatory lead to projects by coordinating regulatory work flow for DCGI and Institutional Ethics Committee submission and approvals, ensuring sufficient regulatory project coverage, providing regulatory support to the team.
• Review and approve investigator site regulatory package documents (Statement of Investigator, investigator CVs, IRB/IEC approval documentation, consent forms, etc.). Work with the appropriate project team members to resolve queries.
• Maintain a working knowledge of, and assure compliance with, applicable ICH & CDSCO Guidelines, Regulatory Agency requirements, and CDSA SOPs.
Head Services
Number of posts : One Post Emoluments: Up to Rs 1,65,000/-
Age : 55 years
Minimum Educational Qualification and Experience
• Graduate in any discipline with MBA (Human Resource Management or Finance) or Chartered Accountant or ICWA.
• Twelve years’ supervisory experience in the relevant field in Central Govt./ State Govt, or autonomous body/ university of Central or State Government.
Job profile
To direct and oversee CDSA’ support services and ensure that all organizational requirements are met relating to operations.
The key responsibilities include the following:
Governance
• Responsible for all governance matters as per the bye-laws / Rules & guidelines of Government of India and those pertaining to the directions issued by the Executive Director or his nominee.
• Work in the Senior Management Team to improve operational systems, processes and policies to support management reporting, and organizational planning.
• Ensure that policies and guidance are in place to clearly define responsibilities, processes, delegations and decision-making powers; and fully comply with Institutional requirements.
HR and Gen Administration
• Undertake and be responsible for the development and implementation of appropriate human resource management policies and practices including recruitment, training and development, performance management, employee grievances, annual appraisals and remuneration for all the project staff of the projects undertaken by the extramural Centre.
• Oversee the various functions including resources and outputs, human resource management, facilities, information, and office administration for the Centre.
Finance and Accounts
• Oversee the job of invoicing, accounting, reporting, and other administrative functions to ensure successful execution of grant process
• Reporting of the timely deliverables and expenditure reports and manage financial sustainability and budgets of the extramural Centre
• Development of budgets in line with concept notes and work plans for various clinical trials and studies undertaken by the Centre.
• Responsible for smooth execution of audits by statutory auditors, internal auditors and donor audit (as applicable) including timely and appropriate resolution of observations
Logistics and Contract management
• Responsible for procurement activities in terms of understanding the specifications of the requirement of various projects sanctioned to CDSA as per existing donor budgets and guidelines and procurement processes / policies of the organization. This will include but not limited to clinical site inventory, procurement of IP drug and purchase of clinical trial Insurance.
• Oversee and manage and evaluate logistics operations, liaising with Vendors, suppliers, logistics providers, transportation companies and customers for conduct of workshop and trainings as well travels undertaken for clinical trial research.
• Develop standards for contracts, including presentation of budget, payment terms, general language and provisions. Ensure the contracts executed for the conduct of the clinical trials are following the existing laws governing staff and patient safety, data safety, conflict of interest disclosures and financial terms if any
Site Management
• Manage relationships, contracts, compliance and interface issues with the different stakeholders including, funding agencies, Sponsors, clinical sites etc. for the sanctioned projects.
• Conduct due diligence that all project funds are applied for intended purpose
• Procurement of equipment, IP drug and other items for site.
IT Management
• Procurement of IT equipment, procurement of regular as well high-end software usage, review of the tenders, bid documents and agreements drafted for the procurement of various IT related services, data backup policy and security risks.
• Development of Sop’s foremail usage, data back-up, website content and other IT activities Complement the activities of the other departments within the team and provide support wherever required.
Perform other duties as assigned by Executive Director, THSTI or Faculty In- charge, CDSA from time to time for smooth the functioning of the program and to achieve program.
Lead- Project Management
Number of posts : One Post
Emoluments : Up to Rs 1,10,000/-
Age : 45 years
Minimum Educational Qualification and Experience : Medical professional qualification or equivalent (MBBS or BDS or BHMS or BAMS or BPT, etc.) Master’s degree in Life Sciences OR Pharmacy OR Public Health 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)
Job profile : 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 manager 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.
Lead- Clinical Science
Number of posts : One post
Emoluments : Up to Rs 1,20,000/- Age: 45 years
Minimum Educational Qualification and Experience
MD from a recognized university with at least 3 years of work experience.
MBBS OR BDS or MPH from a recognized university with at least 6 years of work experience in clinical research especially in clinical operations, study planning and conduct, regulatory function, medical affairs including medical monitoring, medical writing, pharmacovigilance and medical coding and systems for adverse event review and reporting, safety reporting and management.
Job profile : This position is responsible for taking lead during planning stage of assigned clinical studies and trials, development of grant application in terms of study design, study population, safety reporting, budgeting; protocol development. Timely delivery of key tasks, while maintaining high quality standards are key responsibility areas. The lead Clinical Science will manage the performance of the project team(s) working on projects under his/her direction. Mentoring and development of the project team is a key outcome area for this role. The lead Clinical Science will serve as a point of contact for the sponsors and build sponsor relationships. The lead Clinical Science is also responsible for working cross functionally and understanding the implications of management of clinical science and regulatory affairs activities on other groups within the organization. In addition, this role may also have responsibility for managing the regulatory and medical affairs aspect in clinical/ non- regulatory trial directly. The lead Clinical Science will have direct line reports The post will work closely with the Director of CDSA and Head of Medical Affairs and Regulatory Science.
GENERAL TERMS & CONDITIONS
a) For positions at S.No. 1 to 3, 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 two years 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 relax able 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 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 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:
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 personnel@thsti.res.in along with the screenshot of the error displayed (if any).
Last date for receipt of online application : 31 August 2021
The applications will be scrutinised / shortlisted and processed for further selection
Apply Online Link below
Research Scientist (Bioinformatics)
Chief- Clinical Portfolio Management
Head Regulatory Science and Medical Affairs
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