Senior Clinical Data Manager | TMC Software
Summary
• Provide oversight of designated activities outsourced to CROs, external consultants, central and specialist labs, and other data vendors with respect to key performance indicators, metrics, and program level deliverables and timelines. • Proactively organize and perform on-going data review throughout the conduct of the study to ensure timely and appropriate identification of errors, trends, discrepancies, and quality issues. • Keep abreast of literature and advancements in data management technologies, standards, and best practices while informing Clinical Department so they may be considered and/or applied to drug development programs. • Working knowledge of ICH, FDA, CFR, GCP, HIPAA, GCDMP regulations and guidelines, as well as CDISC CDASH standards and SDTM/ADaM specifications. • Ability to work independently as well as collaboratively in a team environment, including liaising with multiple departments (e.g. Regulatory, Clinical Operations, Biostatistics, Medical, Safety, CMC, Translational Research, etc.