Serves as Clinical Data Scientist and Trial Lead for one or more clinical trials
Responsible for all CDIS activities including selection and application of data acquisition standards
May functionally manage a team of Associate Data Managers, Senior Data Managers
Works with Asset Leads to establish strategy, timelines, and adequate resourcing of DMs
Ensures appropriate documentation across the lifespan of the study/asset for all DM deliverables
Provides project management leadership to DM teams
Acts as the key scientific and technical data management expert
Serves as Subject Matter Expert (SME) for and oversees the design, documentation, testing and implementation of clinical data collection tools.
May act as data management contact for regulatory inspections/audits in liaison with the appropriate Quality and Safety groups.

Bachelor’s degree required
Degree in scientific field preferred
Minimum 7 years Data Management experience required
Demonstrated successful experience in all relevant clinical data management activities in a Biopharmaceutical or CRO setting
Working knowledge of all phases of clinical trials
Strong Project and Risk Management
CRO and vendor oversight experience preferred
Strong verbal and written communication skills
Knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements
Proficient experience using commercial clinical data management systems and/or EDC products (Medidata RAVE, Oracle RDC, Inform preferred)
Experience using relational databases (e.g. MS SQL Server, MS Access, or Oracle) and data visualization tools (e.g. Spotfire, jReview)
Strong knowledge of MedDRA/WHO-Drug
Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.).

Senior Clinical Data Scientist

Key skills