THSTI Faridabad
1. 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.
2. THSTI has built several inter-institutional collaborations and connectivity with industry
supported by well-trained teams of research and laboratory staff. This foundation has
helped pursuit of thematic research programmes which can be broadly categorized as, (a)
Infectious diseases and Immunology (b) Maternal and Child Health, (c) Non-communicable
disease (d) Multidisciplinary clinical and translational research. These will be strengthened
by four core facilities viz. Small Animal Facility, Data Management Centre, Biorepository
and Bioassay Laboratory that will serve not only the research programmes of THSTI, but
also the National Capital Region Biotech Science Cluster and other academic and industrial
partners.
3. This recruitment is to fill up the vacancies for project positions at Clinical Development
Services Agency (CDSA) center. CDSA is a niche center 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.
The main objectives of CDSA are:
a) As an academic Clinical Research Unit, to undertake & provide end -to- end
clinical study support for investigators and SMEs in study planning, set up,
conduct: project management, monitoring, data management, safety reporting,
analysis and report writing
b) Build research capacity and capability through high quality training in the area
of clinical development/trials and regulation
c) Support and strengthen clinical research environment in the country
d) Regulatory science and policy support: provide tools and approaches to support
researchers, regulators, health policy makers & industry
Applications are invited from eligible candidates to fill up the following positions:
1. Name of the post
& Project
Project/Program Manager
(DTRC/DBT Neo-Sepsis)
Number of posts Two
Emoluments Up to Rs 1,00,000/-
Age 45 years
Minimum
Educational
Qualification and
Experience
Essential qualification and work experience:
•MBBS/ BDS/ Alliied Medical degree OR
•Master’s degree/ diploma in life sciences, pharmacy, public
health, healthcare or other related discipline OR
•Post graduate 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).
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 protocolspecific 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 Requirements
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 otherstudy 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
teammembers and staff as required
Faculty fortraining projects conducted by CDSA
Any other assignment with Clinical Portfolio Management team,
basedon 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
Influencing skills including negotiation and teamwork
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
andpriorities change
Demonstrated ability to prioritize workload in order to meet
multipledeadlines
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
2. Name of the post
& Project
Clinical Research Associate/Scientist B (Non-Medical)
NBM/DBT Neo-Sepsis/Digoxin/POD
Number of posts Four
Emoluments Up to Rs 60,760/-
Age 40 years
Minimum
Educational
Qualification and
Experience
MBBS/ BDS/ BHMS/ BAMS/ BPT/Bachelor’s in medical sciences or
Master’s degree/ diploma, life sciences, Pharmacy, public health,
healthcare or other related discipline At least 2 years ofrelevant Clinical Research experience
Job profile
The Study Monitor/ CRA conduct monitoring visits for assigned trial
protocol and trial sites. Overall responsibilities are to ensure that the trial
is being conducted in accordance with the protocol, standard operating
procedures, good clinical practice, and applicable regulatory requirements.
Performs site monitoring throughout the trial which involves visiting the
trial sites on a regular basis (site initiation to site closeout) in accordance
with contracted scope of work.
Performs quality functions and executing quality programs (clinical
operations, clinical laboratory) as per GCP/GCLP and regulations
Completes appropriate therapeutic, protocol and clinical research
training to perform job duties.
Setting up the trial sites such that each center has the trial materials,
including the trial drug while ensuring all trialsupplies are accounted for
Administers protocol and related trial training to assigned sites and
establishes regular lines of communication with sites to manage ongoing
project expectations and issues.
May provide training and assistance to junior clinicalstaff.
Creates and maintains appropriate documentation regarding site
management, monitoring visit findings and action plans by submitting
regular visit reports and other required trial documentation.
Manages the progress of assigned studies by tracking regulatory/ IEC
submissions and approvals, recruitment and enrolment, CRF
completion and submission, and data query generation and resolution.
Verifying that data entered on to the CRFs is consistent with
participant clinical notes(source data/ document verification)
Writing visitreports.
Filing and collating trial documentation and reports.
Archiving trial documentation and correspondence.
Evaluates the quality and integrity of trial site practices related to the
proper conduct of the protocol and adherence to applicable regulations.
Escalates quality issues to the Quality Manager, Project Manager and/ or
senior management.
Work with Clinical Portfolio Management on other projects as directed
and other internal departments on their requirements as and when
required.
Skills: -
Computer skills including proficiency in use of Microsoft Office
applications
Basic knowledge and ability to apply GCP and applicable regulatory
guidelines.
Strong written and verbal communication skills including good
command of English required.
Excellent organizational and problem-solving skills.
Effective time management skills and ability to manage
competingpriorities.
Call for application will remain open till suitable candidate are found
Deadline for receipt of application very three weeks of the month.
Will be reviewed on 3rd August,
22 August & 15th September 2022.
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