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
