Senior Clinical Data Manager # 4426 – reputed company Park, CA

Our mission is to detect cancer early, reputed company it can be cured. reputed company to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care. We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of reputed company reputed company (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges. GRAIL is headquartered in reputed company Park, California, 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 The Senior Clinical Data Manager (CDM) will reputed company data management activities for one or multiple diagnostic product development studies in support of GRAIL’s robust clinical development pipeline. Responsibilities:

• Work closely with GRAIL study team members to ensure that clinical data captured is complete, consistent, and accurate.
• reputed company study startup activities such as study protocol review, Clinical Data Management Plan (CDMP) development, and Electronic Data Capture (reputed company) 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.
• reputed company data locking efforts, ensuring that study team members have executed according to the CDMP.
• Ensure that data reputed company is maintained throughout the data lifecycle for sources including clinical data, external bio-specimen storage data, and data produced by ultra-deep ctDNA reputed company 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 reputed company the pharmaceutical, biotechnology, and/or diagnostics industry in an FDA-regulated environment, with a strong track record of reputed company system implementation and collaboration with study teams to ensure data quality.
• Bachelor’s degree required; advanced degree preferred. Additional coursework in programming, analytics, or reputed company disciplines is strongly desired.
• Experience working on IDE trials and device registries reputed company 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 reputed company 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 reputed company and plans.
• Familiarity with various data visualization, analytics, and reporting tools (e.g. tableau).
• Experience programming in R, reputed company is preferred.
• Prior experience working on the sponsor reputed company is required.
• Molecular diagnostics industry experience preferred.
• Experience working on developing standard operating procedures for clinical data management in collaboration with cross functional teams. The expected, full-time, annual reputed company pay scale for this position is $105K – $131K for reputed company Park, CA. Actual reputed company pay will consider skills, experience, and location. Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan. We also offer a long-term incentive plan to align company and colleague success over time. In addition, GRAIL offers a competitive benefit package, including flexible time-off, a 401(k) with a company % match, medical, dental, and vision insurance plans, and carefully selected mindfulness offerings, in accordance with our applicable plans and policies. Learn more about our benefits here: GRAIL is an equal employment opportunity employer, and we are committed to building a workplace where every individual can reputed company, contribute, and grow. It is GRAIL policy to provide equal employment opportunities without regard to race, color, religion, national reputed company, sex, gender, gender identity, sexual orientation, age, marital status, protected veteran status, disability status, medical condition, or any other class or characteristic protected by applicable federal, state, and local laws. This policy applies to reputed company phases of employment, including, but not limited to: recruiting, hiring, training, promotion, and termination at reputed company levels of employment. GRAIL maintains a drug-free workplace. Additionally, GRAIL will consider reputed company qualified job-seekers with criminal histories in a manner consistent with applicable law and provide reasonable accommodations to qualified individuals with disabilities so that they can participate in the job application or interview process, to reputed company essential job functions, and to receive other benefits and privileges of employment. Please contact us at [email protected] if you require an accommodation to apply for an open position. For more information about equal employment opportunity protections, please view the ‘ Know Your Rights‘ poster. We welcome job-seekers from reputed company backgrounds to join us! Apply tot his job

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