CDSA Invites application for post of Project Manager - M.Pharm, M.Sc | Salary Rs 1,00,000/- pm
Clinical Development Services Agency (CDSA) is an extramural unit of Translational Health Science and Technology Institute (THSTI) and has been established as a not-for-profit society to provide cost affective, high quality preclinical and clinical product development support services to meet the country’s growing healthcare needs. It will tend enterprises; particularly SMEs involved in new technology innovation and facilitate translation of scientific know-how into viable products.
Post : Project Manager - POD (1)
Project : (A Phase III, Multicenter, Randomized, Double-blind, Three arm Placebo controlled Trial to Evaluate the Efficacy and Safety of two vaccines in Preventing Tuberculosis (TB) in Healthy Household Contacts of Newly Diagnosed Sputum Positive Pulmonary TB Patients funded by ICMR in Six States of India)
Emoluments : Up to Rs. 1,00,000 per month
Duration : For 2-12 Months
Location : CDSA Faridabad office at NCR Biotech Science Cluster at Faridabad Gurgaon Expressway, Faridabad
Age : Up to 45 years
Project Manager (PM) is responsible for the overall coordination and management of clinical trial from initiation through close out activities. PM oversees the technical and operational aspects of the project. PM collaborates and works closely with other departmental leads (Data management, safety management, and quality management), sponsor and DCPM to identify and evaluate risks and issues on the project and ensure solutions are implemented.
• Oversees project management and quality management processes and provides guidance and support to project teams to meet quality standards.
• Ensure that assigned trial is conducted in accordance with trial protocols, GCP guidelines, GCLP 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 trial staff in good clinical and documentation practices.
• Maintain GCP and GCLP compliant processes which control the quality of work at the trial site
• Oversee and assess trial 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.
• Work with data management to ensure that the data queries are addressed and data is cleaned as per the data management plan.
Qualifications and Experience
• Master’s degree in life sciences or biomedical sciences or pharmacy or Public Health OR
• MBBS / BDS / BHMS / BAMS / BPT OR
• Masters in Clinical Research.
Essential experience: Atleast 4 years of demonstrated experience in the area of clinical research project management and/ or clinical operations and/ or clinical research monitoring, lab monitoring, vendor management and team management.
GCP trained and experience of handling clinical trials will be preferred
• Good understanding of needs for project and job responsibilities.
• Extensive knowledge of GCP, clinical trials and appropriate regulations and guidelines.
• Some knowledge of GCLP
• Ability to develop and implement project management plans, risk management 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)
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