Last Date: 25th February 2019
Clinical Development Services
NCR Biotech Science Cluster, 3rd Milestone
THSTI Building, Faridabad-Gurgaon Expressway
Faridabad, Haryana 121001
Department of Biotechnology (DBT), Ministry of Science & Technology, Government of India launched CDSA on 28 September 2009 as an autonomous organisation and extramural unit of Translational Health Science & Technology Institute (THSTI). It was created to facilitate development of affordable healthcare products for public health diseases. Registered as a not-for profit research organization, it aims to develop 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.
1.Name of the post- Project Manager (District Hospital study funded by BMGF)
Pay Scale- Up to Rs.80,000 per month, for 24 Months.
Location: CDSA Faridabad office at NCR Biotech Science Cluster at Faridabad Gurgaon Expressway, Faridabad
- Oversees quality management processes and provides guidance and support to project teams to meet quality standards.
- Ensure that assigned study is conducted in accordance with study protocols, GCP guidelines, GLP 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 study staff in good clinical and documentation practices.
- Maintain GCP compliant processes which control the quality of work at the study site
- Oversee/Conduct source document verification and case record forms for assessing the study 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.
- Good understanding of needs for project and job responsibilities.
- Extensive knowledge of GCP, observational studies and appropriate regulations and guidelines.
- Ability to develop and implement clinical monitoring plans, SOPs, database concepts, and formats
- Ability to build effective project teams, ability to motivate others, delegation, drive and timely/ quality decision making
- Operational skills including focus and commitment to quality management and problem solving
- Influencing skills including negotiation and teamwork.
- Effective communication skills to provide timely and accurate information to stakeholders
- Ability to assess non-compliance situations and recognize potential or much wider strategic risk to project, escalates when needed.
- Ability to identify systematic causes of complex quality problems and recommend long-term solutions
- Fair and ethical. Creates a culture that fosters high standard of ethics.
- Basic business computer skills (MS Word, Excel, e-mail)
Qualifications and Experience
Master’s degree in life sciences or biomedical sciences or pharmacy or Public Health or MBBS/ BDS/ BHMS/ BAMS/ BPT or Clinical Research. 4-5 years of demonstrated experience in the area of clinical research project management, Clinical operations, clinical research monitoring, lab monitoring, vendor management and team management. GCP trained and experience of handling observational studies will be preferred.
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