Clinical 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, consolidated upto 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 clinical research project management, Clinical operations, clinical research monitoring and team management. GCP 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.
• 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.
• 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 (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
• 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.
Skills
• 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 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)
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GENERAL TERMS & CONDITIONS:
1. All educational professional and technical qualification should be from a recognized Board/ University and full-time.
2. The experience requirement specified should be experience acquired after obtaining the minimum educational qualifications required for the post.
3. Persons working in Govt. or Public Sector undertaking should produce “No Objection Certificate” at the time of Interview.
4. The qualification, experience and other requirements for the post can be relaxed at the discretion of the controlling authority, in case candidates are otherwise well qualified. Interested candidates may please send their current CV with a recent photo and cover letter indicating their motivation for the position applied for (150 words) and three references along with the attached datasheet and excel sheet posted in the website. E-mail should be submitted with subject line Application for the post of “Quality Manager (Preterm Birth Program)” to cdsa_admin@thsti.res.in.
5. Only shortlisted candidates will be contacted for further discussion
6. Incomplete applications will stand summarily rejected without assigning any reasons. 7. 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.
8. This position is strictly project-based and hired only for 8 months.
9. All results will be published on our website and all future communications will be only through email
10. Candidates (Including SC/ST and other backward classes) are not entitled for the travel reimbursement or any other reimbursement.
11. This position will be placed in Gurgaon Civil Hospital, Gurgaon
12. Canvassing in any form will be a disqualification.
Those who have applied earlier need not apply again.
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.
Last Date : May 13, 2018
CLINICAL DEVELOPMENT SERVICES AGENCY
An extra mural unit of THSTI,
Department of Biotechnology, Ministry of Science & Technology, Govt. of India
3rd Floor, THSTI Building, 3rd Milestone,
Gurgaon-Faridabad Expressway, Faridabad – 121001 (Haryana)
Recruitment Notice No. CDS/RN/08/QM-PTB/2018
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