SENIOR CLINICAL DATA MANAGER
SENIOR CLINICAL DATA MANAGER
Clinical Development and Medical Affairs
GRAIL, Inc. is developing paradigm-changing clinical assays for early cancer detection, based on unique biological insights from high-intensity sequencing analysis of circulating cell-free nucleic acids. GRAIL is seeking passionate and talented individuals to join us in realizing this mission, which has the potential to dramatically reduce the global burden of cancer.
The Senior Clinical Data Manager will lead data management activities for multiple diagnostic product development studies in support of GRAIL’s robust clinical development pipeline.
TASKS AND 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 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 and appropriate tools to provide information 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.
- Assist the Director, Clinical Data Management and other GRAIL staff with developing and implementing data standards, controlled procedural documents, and software development efforts.
- 6+ years of industry experience required, 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 strongly desired.
- 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.
- Experience programming in SAS required.
- Molecular diagnostics industry experience preferred.
- Ability to travel as required (up to 20%) preferred.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.