SUMMARY * I am certified-RAVE Study Builder- Certification Sponsored by Cognizant & Medidata USA. I have 12 years of experience in Project Management, Clinical Data Management, Technical Support and Team Management,Overall 10 years of progressive experience in Clinical Data Management domain from study start up till DBL activities. I am experienced with all aspects of data management including project management, edit check writing/reviewing, data locking, eCRF design, full life cycle of study management from Protocol Concept through Database lock. I have been responsible for management and delivery of several phase I-IV clinical trials across the globe thereby consistently handling and meeting the project timelines,Involved in end-to-end Clinical Data Management activities from start up to close out phase(e.g. Project Set up, eCRF Design, UAT, Mapping UAT, ) for various EDC trials. I am a self- starter and quick learner with willingness to learn new and innovative things and meeting the targets on scheduled time, excellent planning and organizational skills, able to manage multiple projects concurrently with the ability to maintain a consistently high standard of work. I have successfully coordinated study team of high performing individuals. Attention to detail and quality and have experience of attending internal and external audits. My functional experience includes Understanding of clinical trial methodology, ICH GCP Guidelines and other guidelines, Good Clinical Data Management Practices,Clinical trials-phase I to phase IV, Drug development, Drug laws and Regulation, Business-development process and medical terminology.I Love training the Data Administration staff on various topics which includes Clinical Research, Clinical Monitoring, Discrepancy Management, Understanding the protocol, other project related documents, DVS-Data validation tool and Study Therapeutic Areas. My therapeutic experience includes Oncology, Infection, Plaque psoriasis etc.

Highlights:

• Management
• Data Management
• Pharmaceutical Industry
• Quality
• Quality Control
• Team Lead
• Document Management
• Audit
• Training
• Quality Assurance