Exciting opportunity for experienced Clinical Data Manager to join the team at a clinical stage biotech company in Gaithersburg, MD.

The Clinical Data Manager will be responsible for data management activities for research studies. This position is responsible for the electronic database design and management including data verification, data cleaning, and quality assurance for multiple projects.

Responsibilities:

• Participates in the design and/or development of study-specific Case Report Forms (CRFs), ensuring consistency with study protocol.

• Collaborates with the project team and other study personnel to determine data collection requirements based on the study protocol and system knowledge.

• Oversees the design of an electronic data capture (EDC) system to mitigate risk while ensuring the cleanliness of clinical data collection.

• Documents and resolves data management issues specific to a protocol. • Assists with communication for internal and external teams to resolve data management issues.

• Creates or reviews data validation check specifications. • Prepares data reports and assists with data presentations as applicable.

• Identifies and resolves data queries and discrepancies. Contributes to data quality metrics for a protocol or project.

• Creates and maintains data management documents per SOP

• Oversees query resolution to verify data quality on regular basis and communicate with clinical team to expedite resolution of queries as well to improve quality of data being collected.

• Organize and maintain clinical study databases and documents to support regulatory submissions to the FDA.

• Supervises contracted clinical research organizations with the design, build and reporting of data from clinical studies.

Heather Mudrick

heather@workforcegenetics.com