Senior Clinical Data Manager # 2687
Remote-USA or Menlo Park, CA
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. GRAIL, LLC is a wholly-owned subsidiary of Illumina, Inc. (NASDAQ:ILMN). For more information, please visit www.grail.com.
The Senior Clinical Data Manager (CDM) will lead data management activities for multiple diagnostic product development studies in support of GRAIL’s robust clinical development pipeline.
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 progressive benefit package, including flexible time-off, a 401k with a company match, and alongside our medical, dental, vision plans, carefully selected mindfulness offerings.
GRAIL is an Equal Employment Office and Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. GRAIL maintains a drug-free workplace.
Following extensive monitoring, consideration of business implications, and advice from internal and external experts, GRAIL US has made the decision to require that all U.S. employees be “Fully Vaccinated” with the COVID-19 vaccine. “Fully Vaccinated” is defined as two weeks after both doses of a two-dose vaccine (e.g. Pfizer or Moderna) or two weeks since a single-dose vaccine (e.g. Johnson & Johnson) has been administered. Absent a qualifying exemption, all GRAIL US employees are to comply with this requirement, including providing documentation of such vaccination status, as a condition of employment. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation for consideration by GRAIL.
The Senior Clinical Data Manager (CDM) will lead data management activities for multiple diagnostic product development studies in support of GRAIL’s robust clinical development pipeline.
You will:
- 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, 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.
- 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.
- Create/review the Data Transfer Plan with External Data Providers or collaborators.
- Assist the Clinical Data Management leadership and other GRAIL staff with developing and implementing data standards, controlled procedural documents, and software development efforts.
Your background and qualifications will include:
- 5+ years of industry experience required in clinical data management within the pharmaceutical, biotechnology, and/or diagnostics industry in an FDA-regulated environment, 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 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. 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 (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.
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 progressive benefit package, including flexible time-off, a 401k with a company match, and alongside our medical, dental, vision plans, carefully selected mindfulness offerings.
GRAIL is an Equal Employment Office and Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. GRAIL maintains a drug-free workplace.
Following extensive monitoring, consideration of business implications, and advice from internal and external experts, GRAIL US has made the decision to require that all U.S. employees be “Fully Vaccinated” with the COVID-19 vaccine. “Fully Vaccinated” is defined as two weeks after both doses of a two-dose vaccine (e.g. Pfizer or Moderna) or two weeks since a single-dose vaccine (e.g. Johnson & Johnson) has been administered. Absent a qualifying exemption, all GRAIL US employees are to comply with this requirement, including providing documentation of such vaccination status, as a condition of employment. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation for consideration by GRAIL.
Tags: Biology Computer Science Data management Data quality Data visualization GCP Pharma R SAS Tableau
Perks/benefits: 401(k) matching Flex hours Flex vacation Health care Salary bonus Startup environment
Regions:
Remote/Anywhere
North America
Country:
United States
Job stats:
8
1
0
Category:
Leadership Jobs
More jobs like this
Explore more AI, ML, Data Science career opportunities
Find even more open roles in Artificial Intelligence (AI), Machine Learning (ML), Natural Language Processing (NLP), Computer Vision (CV), Data Engineering, Data Analytics, Big Data, and Data Science in general - ordered by popularity of job title or skills, toolset and products used - below.
- Open AI Engineer jobs
- Open Lead Data Analyst jobs
- Open MLOps Engineer jobs
- Open Senior Business Intelligence Analyst jobs
- Open Data Engineer II jobs
- Open Sr Data Engineer jobs
- Open Data Manager jobs
- Open Principal Data Engineer jobs
- Open Power BI Developer jobs
- Open Data Analytics Engineer jobs
- Open Junior Data Scientist jobs
- Open Business Intelligence Developer jobs
- Open Product Data Analyst jobs
- Open Senior Data Architect jobs
- Open Data Scientist II jobs
- Open Sr. Data Scientist jobs
- Open Manager, Data Engineering jobs
- Open Business Data Analyst jobs
- Open Big Data Engineer jobs
- Open Data Analyst Intern jobs
- Open Data Quality Analyst jobs
- Open Principal Data Scientist jobs
- Open Data Product Manager jobs
- Open Junior Data Engineer jobs
- Open ETL Developer jobs
- Open Data quality-related jobs
- Open Business Intelligence-related jobs
- Open GCP-related jobs
- Open ML models-related jobs
- Open Data management-related jobs
- Open Privacy-related jobs
- Open Java-related jobs
- Open Finance-related jobs
- Open Data visualization-related jobs
- Open APIs-related jobs
- Open Deep Learning-related jobs
- Open PyTorch-related jobs
- Open Consulting-related jobs
- Open Snowflake-related jobs
- Open TensorFlow-related jobs
- Open PhD-related jobs
- Open CI/CD-related jobs
- Open NLP-related jobs
- Open Data governance-related jobs
- Open Kubernetes-related jobs
- Open Airflow-related jobs
- Open Hadoop-related jobs
- Open Databricks-related jobs
- Open LLMs-related jobs
- Open Data warehouse-related jobs