QUALIFICATIONS • Bachelor’s degree required. Degree in scientific field preferred. Master’s degree preferred. • Minimum 8 years Data Management experience required including 3+ years team leadership • Demonstrated successful experience in all relevant clinical data management activities in a Biopharmaceutical or CRO setting • Working knowledge of all phases of clinical trials and ability to assess and determine study requirement from protocol review • Strong Project and Risk Management • Knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements • Proficient experience using commercial clinical data management systems and/or EDC products (e.g. Medidata RAVE, Oracle RDC / Inform, etc) • Experience using relational databases (e.g. MS SQL Server, MS Access, or Oracle) and data visualization tools (e.g. Spotfire, review) • Familiarity with Med DRA/WHO-Drug coding • Knowledge of risk-based monitoring principles and associated analytics/metrics • Proven experience in vendor oversight to meet aggressive timelines of high quality data deliverables • Strong verbal and written communication skills; independently and effectively in multi-study, multi-disciplinary atmosphere in an matrix environment