James Jolly Tharani
Data Manager
Talent
Hamilton, OntarioMember since October 7, 2024
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About
- Qualified medical research professional skilled in all aspects of Clinical Research including protocols, and participant relationships.
- Demonstrate strong working knowledge of ICH-GCP, company standard operating procedures, regulatory guidelines, protocols and monitoring guidelines. Communicate effectively with team members, stakeholders and vendors.
- Consistently perform at peak professionalism, adhering to code of ethics and company standards. Recognized for initiative, organization, time and management and sound problem solving skills
- More than 9 years of experience working in the field of Clinical Research and delivering Clinical Data and Management objectives in various clinical studies and phases.
- Certified Clinical Data Manager (CCDM) from Society for Clinical Data Management (SCDM)
- Handled multiple projects simultaneously while demonstrating strong leadership in clinical data management activities and leading the Global team.
- Extensive experience in working with Phase I through Phase IV of clinical trials.
- Experience in working on various EDC databases including Medidata Rave, Oracle Clinical (RDC), and Oracle Inform.
- Designed and programmed SAS checks.
- Created and reviewed case report forms (CRFs/eCRFs) and e-CRF completion guidelines.
- Designed reports and metrics for the projects.
- Communicated and coordinated with various global teams in multiple studies.
Experience
- Qualified medical research professional skilled in all aspects of Clinical Research including protocols, and participant relationships.
- Demonstrate strong working knowledge of ICH-GCP, company standard operating procedures, regulatory guidelines, protocols and monitoring guidelines. Communicate effectively with team members, stakeholders and vendors.
- Consistently perform at peak professionalism, adhering to code of ethics and company standards. Recognized for initiative, organization, time and management and sound problem solving skills
- More than 9 years of experience working in the field of Clinical Research and delivering Clinical Data and Management objectives in various clinical studies and phases.
- Certified Clinical Data Manager (CCDM) from Society for Clinical Data Management (SCDM)
- Handled multiple projects simultaneously while demonstrating strong leadership in clinical data management activities and leading the Global team.
- Extensive experience in working with Phase I through Phase IV of clinical trials.
- Experience in working on various EDC databases including Medidata Rave, Oracle Clinical (RDC), and Oracle Inform.
- Designed and programmed SAS checks.
- Created and reviewed case report forms (CRFs/eCRFs) and e-CRF completion guidelines.
- Designed reports and metrics for the projects.
- Communicated and coordinated with various global teams in multiple studies.
Education
- Master of Pharmacy, Dr. MGR Medical University Chennai, Tamil Nadu, India
- Regulatory Affairs, Algonquin College. Ottawa, Canada
