Opportunity for M.Pharm, M.Sc as Project Manager at CDSA | Salary Rs 1,00,000/- pm
Clinical Development Services Agency (CDSA) is an extramural unit of Translational Health Science and Technology Institute (THSTI) and has been established as a not-for-profit society to provide cost affective, high quality preclinical and clinical product development support services to meet the country’s growing healthcare needs. It will tend enterprises; particularly SMEs involved in new technology innovation and facilitate translation of scientific know-how into viable products.
Post : Project Manager
Project : “ NBM Program”
Emoluments : Maximum Up to 1,00,000 per month
Duration : One year
Location : CDSA Office, Faridabad and NBM, BIRAC office, Delhi, based on the allocated work and/or deliverables
Qualifications and 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
Responsible for the management and cross-functional coordination of the program and work closely with Project Management Unit (PMU) of National Biopharma Mission (NBM) to develop and maintain the overall project plan and timelines, communicate project expectations to the respective resource / consultant and manage the overall project budget.
• To oversee the management of a portfolio of trials / studies including project management, quality monitoring and/or safety monitoring and guiding the study teams to achieve successful completion of all assigned activities in the program.
• 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 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
• Assists Clinical management with the development, negotiation, and execution of the site contract, budget and payment plan
• Management of the trial budget(s) and maintenance of the accounts
• 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
• Supervise the study start up activities, trial monitoring and reporting
• Manage distribution, collection and tracking of regulatory documentation to ensure compliance with regulatory and project requirements and audit readiness
• Oversight for planning, preparing, and distributing materials for investigator and coordinator meetings, and for study related training
• Work with data management and other departments to track progress, milestones and the challenges
• Works Closely with: Project Team at CDSA, NBM and the site, Sponsors, clinical collaborators, Expert groups / Committee, Regulatory Affairs, Medical Affairs, Data Management, Biostatistics, Laboratory team, key Institute staff on finance, administration, contracts and personnel matters.
• Continually review and respond to changes required to shape the infrastructure, functionality and standards of the program management
• Oversee / Coordinate and draft Memorandum’s of Understanding (MoU’s) or other documents to outline the delegation of duties from the sponsor office to CDSA, NBM and other stakeholders of the projects.
• Support Director CPM for escalations and trouble shooting where issues or concerns are raised by PMU-NBM /researchers with regards to the projects under the program
• Ensure consistent application of core CDSA policies and operating procedures across the NBM program
• Track resources and actual time spent on each project task for all team members to evaluate project progress and CDSA commitment towards NBM
• Communicate to team members the scope of work, timeline and project goals, technical information or update, and input from NBM
• Communicate fiscal, contractual, resource, deliverable and client-related issues to Director CPM as appropriate
• Provide guidance and operational area training for project team members and staff as required
• Act as mentor for study staff and oversight for their training and development.
• Faculty for training programs conducted by CDSA
• Any other assignment with Clinical Portfolio Management team, based on project deliverables or exigencies
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