Career for Life Sciences, Pharma candidates at CDSA | Pay upto Rs. 1,00,000 pm

Translational Health Science and Technology Institute 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. 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.

Consultant Project Manager/Project Scientist -II/Project Manager (04 Positions)
Name of the Study : Digoxin Study/POD Study/Indigo Study/DTRC
Age Limit : 45 years
Emoluments : Up to Rs. 70,000/- to Rs. 1,00,000/-
Duration : For 2-12 Months Location CDSA, THSTI, NCR, Biotech Science Cluster, Faridabad
Essential qualification and work experience :
• MBBS/ BDS/ Alliied Medical degree OR
• Ph.D/Master’s degree/ diploma in life sciences, pharmacy, public health, healthcare or other related discipline OR
• A minimum of 2 years’ experience in Clinical Project Management and/or Clinical trial/Study monitoring Post Ph.D or 5 years experience Master’s degree/M.B.B.S/B.D.S
• 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 qualification and work experience :
• Postgraduate degree in Public Health
• MD/DNB from a recognized Indian University/ recognized by MCI
• PhD 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 project budget.
• 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.

Skills: -
• Leadership skills that include the ability to build effective project teams, ability to motivate others, delegation, drive and timely/quality decision making
• Personal qualities that include the ability to gain trust and confidence with a variety of clients, good learning ability, managerial courage, action oriented and resilience in a fast- paced and rapidly changing environment
• Comprehensive understanding of Indian Clinical Trials Regulations, ICH and CDSCO Good Clinical Practice
• Business/ Operational skills that include commitment to quality management and problem solving
• Effective communication skills that include the provision of timely and accurate information to stakeholders, proficient in English, strong written and oral communication skills
• Computer literacy in Word, Excel, PowerPoint, Access or other trial management systems
• Ability to develop and deliver presentations, prepare technical reports and contribute effectively in the manuscripts
• Ability to develop and implement monitoring plans and SOPs
• Ability to make evaluative judgments, remain flexible as projects and priorities change
• Demonstrated ability to prioritize workload in order to meet multiple deadlines
• Ability to work independently with minimal guidance as well as collaboratively within a team setting
• Knowledge of regulations and guidelines pertaining to the conduct of clinical trials/ studies on human subjects
• Influencing skills including negotiation and teamwork

Consultant (Medical Monitor) (01 position)
Name of the Study : (A Phase III, Multicenter, Randomized, Double-blind, Three arm Placebo controlled Trial to Evaluate the Efficacy and Safety of two vaccines in Preventing Tuberculosis (TB) in Healthy Household Contacts of Newly Diagnosed Sputum Positive Pulmonary TB Patients funded by ICMR in Six States of India)
Age Limit : Up to 45 Years
Emoluments : Rs. 84,400 per month (consolidated)
Duration : For 2-12 Months Location CDSA, THSTI, NCR, Biotech Science Cluster, Faridabad
Educational qualification and work experience :
• MD/MS or Postgraduate diploma from recognized university with 2 years of R&D experience OR
• MBBS/BDS or Allied medical degree from recognized University with 5 years R&D experience
Desirable work experience :
• Candidate with relevant experience in medical affairs and/ or medical monitoring of research projects will be preferred Past experience of working on Vaccine projects and / or regulatory studies will be an advantage.

Job profile The roles & responsibilities of Medical Monitor (MM) are as follows but not limited to :
• The MM, in consultation with safety oversight committees, will provide safety review during the execution of the clinical trial as per the pre-defined and approved safety management plan. This oversight includes reviewing safety information and providing applicable recommendations.
• Interpretation of single and/ or grouped adverse events, serious adverse events, drug effect and attribution of causality, and disease condition
• Educating, training, and mentoring research teams in safety monitoring and reporting
• Conduct on-site medical monitoring visit and communicate the observations through detailed visit report
• Assist sponsor in preparation of expedited and periodic reports
• Review of clinical narrative reports describing the event and support in finalization
• Participate in development of CRF, statistical analysis plan (SAP), DMC charter and other documents as required by the study.
• Participate in study management team meetings, DMC and technical review meetings, as required.
• Interact with investigative sites, address protocol/medical questions in consultation with sponsor medical monitor
• Perform review of data generated by data listings or statistical analyses.
• Review medical coding of safety data
• Review individual data with SAEs and potentially clinically important laboratory test or vital sign abnormalities.
• Participate in all reviews and procedures required for database lock.
• Provide Study Team with medical expertise during key activities
• Contribute to, draft and / or edit Clinical Study Reports (CSR)
• Assist in development of scientific meeting abstracts and presentations as well as manuscripts Any other assignment with Clinical Portfolio Management team, based on project deliverables or exigencies.

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 of GCP, regulations and guidelines
• Knowledge of adverse medical event investigation, analysis, and reporting procedures and standards
• Fair and ethical. Creates a culture that fosters high standard of ethics.
Basic business computer skills (MS Word, Excel, e-mail)

GENERAL TERMS & CONDITIONS:
a) For position 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) These are short term positions with a probation period of three 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 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.
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) All results will be published on our website and all future communications will be only 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) With regard to any provisions not covered in this notification, the bye laws of THSTI / Govt. of India rules / guidelines shall prevail.
k) Canvassing wrong in any form will be a disqualification.
l) 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 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 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 236/-
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).