Job opportunity for M.Pharm at NCR Biotech Science Cluster - Ministry of Science & Technology - Salary Rs. 70000 per month

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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 : Research Officer (iKMC Study), 01 Position

Age Limit Upto 40 Years

Emoluments/ Duration : Rs. 75,000/- per month consolidated, 30 Months

Location : NCR Biotech Science Cluster, Faridabad

Job profile

    1. Oversees quality management processes and provides guidance and support to project teams to meet quality standards.
    2. Advising and providing training to research team on interpretation of GCP/ethical requirements on biomedical research for quality management.
    3. Overseeing and/or performing quality functions and executing quality programs (clinical operations, data collection, management and transmittal)
    4. Developing quality management plan and ensuring compliance
    5. Setting up documentation standards and ensure compliance throughout the study span
    6. Identifying areas of deficiency and trends in quality and escalating to appropriate personnel
    7. Collaborate with clinical and project coordination team to ensure compliance with quality standards, timelines and appropriate followup in areas of deficiency
    8. Coordinate expert monitoring visit/ audits as per project requirement.
    9. Educating, training, and mentoring research team in quality improvement methods
    10. Supervise quality management team to ensure efficient monitoring of all the study components, reporting and follow-up for corrective and preventive action.
    11. Work with Clinical Portfolio Management and other internal departments on their requirements as and when required

    Qualifications and Experience
    Medical or allied bachelor’s degree or Masters in life sciences/ pharmacy/ healthcare or other related discipline. At least 5 years of demonstrated experience in the area of Management, Quality Assurance and/or Clinical operations of clinical trials / research projects. GCP trained and experience of handling field based studies will be preferred.

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