PROFESSIONAL SUMMARY: *rong knowledge of clinical data management, clinical trials and related areas with ~8 years of experience in CRO and Pharma industry. *tensive work experience through all phases of Clinical Data Management (CDM) starting with data validation, project initiation, requirement gathering, requirement analysis, database design, report- ing and central file documentation. *und knowledge about clinical trial and its regulatory requirements. *rked as a lead on clinical trial start-up, maintenance and close-out activities. *oficiency in supervising analytical work & documentation as per Industry Regulations & various other Regulatory Authorities. *miliar with Mapping requirements & best solutions involving evaluation & definition of scope of project and finalization of project requirements. *ceptional project management, including managing multiple complex projects from start to com- pletion. *rong therapeutic experience in Oncology and Immunology. Proficient with RECIST 1, 1.1, NADIR Point, RANO criteria. *miliar with Orphan Drugs and Rare Diseases. *ficient knowledge on FDA regulations and familiarity with web-based Electronic Data Capture (EDC), Clinical Trial Management Systems (CTMS) and coding dictionaries such as WHODD, MedDRA. *und Knowledge of ICH-GCP and other applicable local and international regulations such as 21 CFR Part 11. *s part of a Technical training team and have provided various trainings on SDTM (Study Data col- lection model), Medidata Rave and various CDM Processes. *ility to use of SAS statistical analysis software if required and familiar with CDISC Standards. *sured project completion within timelines as per quality parameters, determining resource needs and identifying scope of work under the supervision of GDM (Global Data Manager). *ad the DM team while managing customer relationships for the project team that included active participation in customer negotiations related to timeline, budgets and other issues. *sponsible for conducting and documenting project-specific training for all team members prior to project start and throughout the course of the project as needed. *naged and coordinated with third party vendors specifically related to data collection, review, analysis and communication on project timelines. *ined Extensive Experience on following Data Base Tools: Medidata Rave, OC-RDC, Inform Phase Forward and Data Labs. *view clinical templates and documents for accuracy like Informed Consent, Source documents, TMF's (trial master files) and CTMF software. *rong skills in Excel, and the ability to work with multiple databases in an electronic environment. *miliar with Generating figures, tables, and listings (TLFs) for study reports and regulatory sub- missions as needed. *miliar with handling of Stats issues and provide resolution for the same as per requirements. *ecialties: Creation and review of Data Management Plan (DMP), CRF Designing, User Acceptance Testing (UAT), eCRF completion Guidelines, SOP Implementations, Vendor Data Agreements, SAE Plan, Dash board life cycle metrics (DBLM), project management skills, QC, internal audits, good documentation practices and interpersonal skills. *CHNICAL SKILLS:

Highlights:

• Management
• Protocol
• Metrics
• Quality
• Quality Assurance
• Coding
• Data Management
• Training
• Assessments
• CDM