Senior Clinical Data Manager
Posted on 6/7/2022
Menlo Park, CA, USA
Google Cloud Platform
- Bachelors degree required; advanced degree preferred. Additional coursework in programming, analytics, or related fields strongly desired
- 5+ years of industry experience required, with a strong track record of EDC system implementation and collaboration with study teams to ensure data quality
- Knowledge of clinical trials and medical device and/or drug development processes. Experience working on study start up, database locks, analysis timepoints and study closeout
- Knowledge of regulatory requirements and information governance frameworks (e.g. ICH, GCP, HIPAA. GDPR)
- 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
- Some local and international travel may be required
- Molecular diagnostics industry experience preferred
- Contribute to GRAIL's clinical programs such as MSK and STRIVE studies from a clinical data management perspective
- Work closely with GRAIL study team members and strategic partners 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 Software Engineering staff to develop internal applications and 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
- Use 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 toward the goal of achieving analysis-ready datasets
- Ensure that data integrity is maintained throughout the data lifecycle for sources including clinical data, and bio-specimen data
- Ensure that documentation is maintained in a state of constant audit-readiness and filed in the Trial Master File
- Collaborate with the CDM team and cross-functional GRAIL staff while developing and implementing data standards, authoring controlled procedural documents, and contributing to software development efforts
- Experience working on studies under the purview of the FDA and MHRA is a plus
- Prior experience programming with SAS, R or Python is a plus. Ability to work hands on with data using spreadsheet software required
- Prior experience with software systems development and integration, EDC programming/configuration, or APIs is a plus
Designs cancer screening tests
GRAIL's mission is to detect cancer early, when it can be cured. They are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care.
- Outstanding People - Join a team of passionate and dedicated professionals, committed to collaboration, education, and proactive problem-solving.
- Strong Compensation - We offer competitive salaries and savings plans to provide for long-term financial planning.
- Complete Health Coverage - Take advantage of comprehensive health coverage, with medical, dental and vision, to keep you and your family healthy.
- Work-Life Balance - Make everyday life more manageable with flexible time off – we trust you to do great work and take time for yourself.
- Grit - We are determined and resilient because patients are counting on us.
- Respect - We value diversity and challenge each other respectfully.
- Accountability - We own our decisions and keep our commitments.
- Integrity - We adhere to our principles of humility, transparency, and rigor.
- Leadership - We make each other better by making leadership everyone’s responsibility