Sr. Clinical Data Manager (Contract)

Employer
GRAIL, Inc.
Location
Menlo Park, CA, United States
Posted
Jun 25, 2021
Ref
2063144963
Discipline
Clinical, Clinical Data
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Contract
GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit www.grail.com.

We are looking for a Sr. Clinical Data Manager to execute data management activities for multiple clinical studies in support of GRAIL's robust product development pipeline! This position will have the opportunity to work on large, multi-center clinical trials, and make significant contributions to the future of early cancer detection!

You Will:

• 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.
• 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 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.

Your Background Should Include:

• 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.
• Experience working on studies under the purview of the FDA and MHRA is a plus.
• Familiarity with various data visualization, analytics, and reporting tools.
• 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.
• Some local and international travel may be required.
• Molecular diagnostics industry experience 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.

GRAIL, Inc. and its affiliates and subsidiaries ("GRAIL") does not accept any liability for fees for resumes from recruiters or employment agencies ("Agency"), without a binding, written recruitment agreement between GRAIL and Agency describing the services and specific job openings ("Agreement"). GRAIL may consider any candidate for whom an Agency has submitted an unsolicited resume and explicitly reserves the right to hire those candidate(s) without any financial obligation to the Agency, unless an Agreement is in place. Any email or verbal contacts with any person within GRAIL is inadequate to create a binding agreement. Agencies without an Agreement are requested not to contact any hiring managers of GRAIL with recruiting inquiries or resumes. Agencies interested in partnering with GRAIL may contact GRAIL's HR Department through our Customer Service team .