Shalini Ramesh Email & Phone Number

Professional Summary:1. Seasoned Senior Clinical Data Manager with a proven track record of problem-solving, diagnosis, and analysis while maintaining data integrity and compliance with FDA regulations and CDISC/CDASH including the SDTM model, GCDMP, 21 CFR Part 11, FDA, and ICH GCP safety reporting requirements. 2. Capable in managing intricate clinical data management duties and directing teams.3. Significant expertise in developing protocol-specific guidelines, constructing study-specific CRFs, and overseeing Data Management Plans (DMP). 4. Proficient in utilizing Electronic Data Capture (EDC) and Management systems, including Medidata Rave and InForm.5. Holds strong and holistic Clinical Data Management skills, spanning study start-up, conduct, and closeout activities, with hands-on experience in various critical tasks.6. Successfully managed relationships with external vendors such as Clinical Research Organizations (CROs), laboratories, and data management service providers, ensuring adherence to project timelines and quality standards. 7. Perform protocol review, Case Report Form (CRF/eCRF) design, database construction, validation of edit checks, and discrepancy management as well as planning, implementation, and general direction of clinical trial data management aspects.8. Collaborated closely with cross-functional teams including bio statistics, clinical operations, and external vendors to ensure seamless data management and project delivery within timelines.9. Possesses extensive knowledge in Data Management processes, including Serious Adverse Event (SAE) reconciliation, external data vendor reconciliation including PK/PD, Immunogenicity, and Safety labs and adaptability to new technology, with a basic understanding of medical coding using MedDRA and WHO Drug dictionaries.10. Involved in custom reporting using tools like Business Objects, SAS, and Crystal Reports, with a strong understanding of Medidata Rave Study Build.11. Experienced in compiling, updating, and maintaining Trial Master Files.12. Developed reports using J-Review and other report extraction tools. 13. Known for a strategic, detail-oriented, multi-tasking, creative, and quality-focused approach.14. Exhibits excellent project management skills, strong interpersonal skills, organizational expertise, and exceptional written and verbal communication skills, fostering effective teamwork and adept problem-solving abilities.15. Demonstrates the ability to establish and maintain effective working relationships with co-workers and managers.