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 : Program Manager – CPM, CDSA
Emoluments : Up to Rs 1,00,000/- per month
Duration : (One Year)
Location : CDSA Office, Faridabad
Age Limit : Upto 45 Years
Qualifications and Experience
• Bachelor’s in medical sciences or Master’s degree/ diploma in life sciences, pharmacy, public health, healthcare or other related discipline
• MBBS/ BDS/ BHMS/ BAMS/ BPT preferred or
• Post graduate degree in a health related discipline
• Postgraduate degree in Public Health
• MD/DNB from a recognized Indian University/ recognized by MCI
• PhD in a health related discipline
• 8 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)
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• Demonstrable experience of leading a team
• Experience of line management
• Demonstrable application of project management concepts
• Demonstrated ability to understand, explain and communicate project concepts (project life cycle, scope planning, scheduling, implementation of project plan), and manage project conduct (schedule, quality, and cost control, risk and change management) using standard tools and templates
• Excellent interpersonal skills
• Experience of managing a complex public health study/ clinical trial of an IMP
• Highly developed communication skills both written and verbal
• Significant experience of project management in industry, major academic clinical trials unit or epidemiological/public health research setting
• Comprehensive understanding of Indian Clinical Trials Regulations, ICH and CDSCO Good Clinical Practice
• Ability to evaluate risks inherent in clinical studies/ trials and decide those which should be prioritized to ensure that risks are properly managed
• Outstanding organizational skills, managing several projects that are often time pressured, concurrently. Ability to prioritize activities in spite of conflicting pressures.
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• 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 project
• To support the Director CPM and other team leads in the implementation of systems for resource planning, study/trial administration and document management, data management and quality assurance.
• To contribute to research in design and conduct of trials/studies.
• Provides Leadership to: Project Manager/ Clinical Trial Manager, Senior Research Officer/ Research Officer, Clinical Research Associate/ Study Monitor, and Project/Clinical Trial Assistant.
• Has direct line management responsibility for upto 5 Project / Clinical Trial Managers
• Works Closely with: Project Team Members, Site Study team (Project Coordinator, Investigators), Expert groups/ Committee, Regulatory Affairs, Medical Affairs & Medical Writing, Data Management, Biostatistics, Central Laboratory, key Institute staff on finance, administration, contracts and personnel matters.
• External relationships: Investigators, Clinical collaborators, Sponsor counterparts and management, third party contractors and regulatory authorities.
Note : In case a suitable candidate is not found, the call for application will remain open till suitable candidate is found. As soon as suitable candidate is found, this recruitment notice will be closed on our website.
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