Experienced Clinical Data Lead with a robust skill set in all facets of clinical data management. Proficient in study setup, database design, data validation, query management, coding, and reconciliation. Well-versed in CDISC standards (SDTM and ADaM) and adept at utilizing clinical data management systems like Medidata Rave and Oracle Inform. Proven leader with the ability to mentor teams, providing guidance for successful project execution. In-depth knowledge of FDA and ICH guidelines ensuring compliance in clinical data management. Exceptional written and verbal communication skills to facilitate collaboration with cross-functional teams, investigators, and vendors. Detail-oriented and quality-focused, excelling in project management within established timelines and budgets. Strong leadership and interpersonal skills effectively contributing to project success.