Career for M.Pharm, M.Sc in Preterm Birth Program at CDSA - Government Job | Emoluments Upto Rs. 55,000 pm

CDSAClinical Development Services Agency (CDSA) has therefore been formed as a not-for-profit society to provide supportive and focused environment to host world class clinical translation through a collaborative network of clinical investigators and premier research institutions.  It will tend enterprises, particularly SMEs involved in new technology innovation, to facilitate translation of scientific know-how into viable products for public health diseases like malaria, tuberculosis and dengue among others.

Post : Quality Manager (Preterm Birth Program)

Emoluments/ Duration
Up to Rs. 55,000 per month up to December 2018 likely to be continued

Qualifications and Experience
Master’s degree in life sciences or biomedical sciences or pharmacy or Public Health or Clinical Research. 4-5 years of demonstrated experience in the area of Quality Control, Quality Assurance and Clinical operations. GCP/ GLP trained and experience of handling observational studies will be preferred.

Job profile
Oversees quality management processes and provides guidance and support to project teams to meet quality standards.
• Actively lead or assist activities in the areas of Internal Quality improvements and CAPA (Corrective and Preventive Actions).
• Ensure that assigned study is conducted in accordance with study protocols, GCP guidelines, and applicable regulatory requirements.
• Lead or assist with identifying non-conformances with requirements, provide suitable recommendations and facilitate ongoing quality improvements using risk-based methodology.
• 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
• Conduct source document verification and case record forms for assessing the study trends
• Overseeing and/or performing quality functions and executing quality programs (clinical operations, clinical laboratory, data management review)
• Collaborate with clinical and project management team 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

Skills
• Good understanding of needs for project and job responsibilities.
• Extensive knowledge of GCP/GLP, 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 real 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)

Location : Gurgaon Civil Hospital, Gurgaon

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