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James Jolly Tharani

James Jolly Tharani

Data Manager

Pharmaceutical / Bio-tech

Hamilton, Ontario

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About James Jolly Tharani:

 

  • 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

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