Career for M.Pharm, M.Sc as Senior Research Officer at Clinical Development Services Agency | Emoluments upto Rs. 75,000 pm
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 : Senior Research Officer (Zinc Sepsis Study)
Emoluments/ Duration : up to Rs. 75,000 per month, consolidated for 20 months
Location : NCR Biocluster, Faridabad
• Oversees quality management processes and provides guidance and support to project teams to meet quality standards.
• Advising and providing training to research team on interpretation of GCP/ethical requirements for quality management.
• Overseeing and/or performing quality functions and executing quality programs (clinical operations, clinical laboratory, data management review)
• Developing quality management plan and ensuring compliance
• Ensure compliance with agreed upon documentation practices
• Identifying areas of deficiency and trends in quality and escalating to appropriate personnel
• Setting up documentation standards and ensure compliance throughout the study span
• 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.
• Educating, training, and mentoring research team in quality improvement methods
• Supervise quality management team to ensure efficient clinical monitoring (site preparedness, study initiation, interim monitoring, close out & termination), archiving, reporting and follow-up for corrective and preventive action.
• Travel up to 50%, as assigned
• Quality assurance through external monitoring Work with Clinical Portfolio Management and other internal departments on their requirements as and when required
Qualifications and Experience
Master’s degree in life sciences or biomedical sciences or pharmacy. At least 5 years of demonstrated experience in the area of Quality Control, Quality Assurance and Clinical operations. GCP/ GLP trained personnel will be preferred.
• Good understanding of needs for project and job responsibilities.
• Extensive knowledge of GCP/GLP and appropriate clinical research regulations and guidelines.
• Ability to develop and implement clinical research 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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