Data Manager leading a team of engineers to enhance data architecture and analysis capabilities at Huckberry. Overseeing data projects to meet business goals while ensuring quality and efficiency.
About the role
- Managing data activities for diagnostic product development studies at GRAIL. Ensuring data quality and integrity while collaborating with study teams in a healthcare environment.
Responsibilities
- Lead data management activities for one or multiple diagnostic product development studies
- 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
- 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
- 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
Requirements
- 5+ years of industry experience required in clinical data management within the pharmaceutical, biotechnology, and/or diagnostics industry in an FDA-regulated environment
- 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
- 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
Benefits
- Flexible time-off
- 401(k) with a company % match
- Medical, dental, and vision insurance plans
- Mindfulness offerings
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