Clinical Development Services Agency (CDSA) is an extramural unit of Translational Health Science and Technology Institute which is an autonomous institute created by the Department of Biotechnology (DBT), Ministry of Science & Technology, Government of India to strengthen the existing clinical trial / study capacity for affordable health care products in India and raise it to international standards. It is committed to strengthening and expanding the evidence base for healthcare nationally. CDSA has a national reputation for assisting academic investigators, bio-pharma entrepreneurs and innovative SMEs in the delivery of clinical trials and cohort studies throughout their life cycle from set up to closure. Over time, and building on current strengths, the mission of the Clinical Portfolio Section of CDSA is to become a centre of excellence that supports the conduct of Phase III/IV clinical trials and epidemiological studies of national importance.
Post : Quality Manager (ADBS Study)
Emoluments : (Up to Rs. 80,000 per month, consolidated) for 36 Months subject to annual performance review.
Location : NIMHANS, Bengaluru
Job profile
The roles & responsibilities of Quality Manager are as follows but not limited: The Quality Manager, in consultation with the QM oversight lead at CDSA and the Principal Investigators (PIs), conduct monitoring at the study site (NIMHANS) to ensure compliance with GCP / applicable study requirements and provide recommendations for highest standards of study conduct, recording and reporting.
This will include:
• Manages study operational plan – project timeliness and quality of deliverables.
• Ensure that assigned study is conducted in accordance with sponsor protocols, GCP guidelines, applicable regulatory requirements.
• Develop and maintain GCP/ICH 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
• Actively lead or assist activities in the areas of Internal Quality improvements and CAPA (Corrective and Preventive Actions).
• Prepare study monitoring plan and required SoPs for the quality monitoring
• 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.
• Manage and maintain databases for the quality systems.
• Maintain the study master file and review the site master file for the appropriate updation throughout the study span
• Prepare and assist in preparing annual reports and quality trending reports.
• Participate in study management team meetings and represent the QM team.
• Work closely with other teams at CDSA and the study site
Qualifications and Experience
• MBBS / BDS / MPH / Allied medical degree from recognized university with at least 3 years of clinical research experience OR
• Post – graduate degree in life-sciences / Clinical Research, nursing, or related fields with minimum 3 years of clinical research experience, with 2-3 years as Team lead/ Project Manager for clinical trials/ research project.
• Candidate with monitoring and/ or M&E experience of the public health study will be preferred.
Age limit : Not exceeding 40 years
Skills
• Ability to gain trust and confidence with stakeholders.
• Operational skills including focus and commitment to quality management and problem solving
• Influencing skills including negotiation and teamwork
• Effective communication skills, the provision of timely and accurate information to stakeholders
• Understanding of GCP, regulations and guidelines
• Knowledge of adverse medical event investigation, analysis, and reporting procedures and standards • 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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