Monday, September 5, 2022

Program Manager/Clinical Research Associate

 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. 

More Info: https://thsti.in/ethsti/writereaddata/165790227264Advt.-No.-THS-C-RN-06-2022.pdf

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