Senior Clinical Data Manager #4239

Responsibilities:

• Work closely with GRAIL study team members to ensure that clinical data captured is complete, consistent, and accurate.  
• Perform study startup activities such as study protocol review, Clinical Data Management Plan (CDMP) development, and Electronic Data Capture (EDC) set-up, while collaborating with Clinical Technology staff to integrate with external systems.
• Manage study conduct activities including facilitation of study team data review, documentation of data handling decisions, issuance of data queries and resolution of data discrepancies.
• Utilize programming skills to create listings and dashboards as required by study team members.
• Lead data locking efforts, ensuring that study team members have executed according to the CDMP.
• Ensure that data integrity is maintained throughout the data lifecycle for sources including clinical data, external bio-specimen storage data, and data produced by ultra-deep ctDNA sequencing laboratories.
• Ensure that documentation is maintained in a state of constant audit-readiness and filed in the Trial Master File.
• Create/review the Data Transfer Plan with External Data Providers or collaborators.
• Assist Director of Clinical Data Management and other GRAIL staff with developing and implementing data standards, controlled procedural documents, and software development efforts.

Preferred Qualifications & Background:

• 5+ years of industry experience required in clinical data management within the pharmaceutical, biotechnology, and/or diagnostics industry in an FDA-regulated environment, with a strong track record of EDC system implementation and collaboration with study teams to ensure data quality.
• Bachelor’s degree required; advanced degree preferred. Additional coursework in programming, analytics, or related disciplines is strongly desired.
• Experience working on IDE trials and device registries within the medical device and/or pharmaceutical industry.
• Prior experience leading mid to large scale clinical trials and ability to support multiple projects at a given time. 
• Experience working with EDC systems.
• Knowledge of regulatory requirements (e.g. ICH, GCP, HIPAA).
• Strong interpersonal communication (written and verbal) and organizational skills.
• Excellent team player with demonstrated track record of success in a cross-functional team environment. Consistent commitment to delivering on team goals with a sense of shared urgency.
• Experience managing vendors and partnering with collaborators to deliver according to contracts and plans.
• Familiarity with various data visualization, analytics, and reporting tools (e.g. tableau).
• Experience programming in R, SAS is preferred.  
• Prior experience working on the sponsor side is required.
• Molecular diagnostics industry experience preferred.
• Experience working on developing standard operating procedures for clinical data management in collaboration with cross functional teams.