Last Date: 29th July, 2019
CLINICAL DEVELOPMENT SERVICES AGENCY
3rd Floor, THSTI Building, 3rd Milestone
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.
1.Name of the Post- Project Manager POD(1)
Pay Scale- Maximum Up to 1,00,000 per month
- Project Manager (PM) is responsible for the overall coordination and management of clinical trial from initiation through close out activities. PM oversees the technical and operational aspects of the project. PM collaborates and works closely with other departmental leads (Data management, safety management, and quality management), sponsor and DCPM to identify and evaluate risks and issues on the project and ensure solutions are implemented.
- Oversees project management and quality management processes and provides guidance and support to project teams to meet quality standards.
- Ensure that assigned trial is conducted in accordance with trial protocols, GCP guidelines, GCLP guidelines and applicable regulatory requirements.
- Lead or assist with identifying non-conformances with requirements, provide suitable recommendations and facilitate ongoing quality improvements.
- Proactively identify the project risks and assist in providing training to trial staff in good clinical and documentation practices.
- Maintain GCP and GCLP compliant processes which control the quality of work at the trial site
- Oversee and assess trial trends
- Overseeing and/or performing quality functions and executing quality programs (project management, clinical operations, clinical laboratory, data management review) Collaborate with clinical and other stakeholders to ensure compliance with quality standards, timelines and appropriate follow-up in areas of deficiency
- Coordinate expert monitoring visit/ audits as per project requirement.
- Work with Clinical Portfolio Management and other internal departments on their requirements as and when required
- Actively lead or assist activities in the areas of Internal Quality improvements and CAPA (Corrective and Preventive Actions)
- Manage team of study monitors
- Guide and mentor the study monitors for project deliverables
- Perform project management tasks including the management of project meeting organization for investigator meetings, steering committee meetings etc.
- Work with data management to ensure that the data queries are addressed and data is cleaned as per the data management plan.
GENERAL TERMS & CONDITIONS
- All educational professional and technical qualification should be from a recognized Board/ University and full-time.
- The experience requirement specified should be experience acquired after obtaining the minimum educational qualifications required for the post.
- Persons working in Govt. or Public Sector undertaking should produce “No Objection Certificate” at the time of Interview.
- The qualification, experience and the number of position and other requirements for the post can be relaxed at the discretion of the controlling authority, in case candidates are otherwise well qualified.
- Only shortlisted candidates will be contacted for further discussion
- Incomplete applications will stand summarily rejected without assigning any reasons.
- The salary is a consolidated sum as per sanctioned order without any other benefits. Salary mentioned against the position is an actual and will be based
on experience, qualifications, skill set, etc. of the candidates.
- This position is strictly project-based and hired only for 2-12 months.
- All results will be published on our website and all future communications will be only through email
- Candidates (Including SC/ST and other backward classes) are not entitled for the travel reimbursement or any other reimbursement.
- This position will be placed in CDSA Faridabad office at NCR Biotech Science Cluster at Faridabad Gurgaon Expressway, Faridabad.
- Canvassing in any form will be a disqualification.
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