Clinical Data Manager
Thrive Earlier Detection, United States

Experience
1 Year
Salary
0 - 0
Job Type
Job Shift
Job Category
Traveling
No
Career Level
Telecommute
No
Qualification
As mentioned in job details
Total Vacancies
1 Job
Posted on
Mar 13, 2021
Last Date
Apr 13, 2021
Location(s)

Job Description

A cancer diagnosis is something no one wants to hear. Too often, cancer is detected late, once it has spread and treatment options are limited. But cancer can be more effectively treated with an intent to cure if caught in the earlier stages. At Thrive, an Exact Sciences Company, our goal is to transform this outlook: to catch cancer earlier, including several with no screening options today, to improve patient outcomes. We are developing a blood-based test that is designed to be affordable and utilized as part of routine medical care to detect multiple types of cancer at earlier stages. Our approach goes beyond a cancer diagnosis. We are developing a platform that will serve as a resource to help patients and their families maneuver the often confusing and overwhelming path that follows a cancer diagnosis.
At Thrive, we are motivated to change the face of a cancer diagnosis. We challenge the status quo and are willing to think differently. Our curiosity drives us. There are countless questions related to cancer, and we flourish by finding solutions. We know what we do is important, and we take our work seriously. We also have fun. We do our work with vibrant energy, and we laugh out loud at the little things. This is How We Thrive.
Position OverviewServes as the lead project or program data manager on Thrive development projects and in collaboration with external vendors with responsibility for managing the design, implementation, and maintenance of electronic case report forms, and electronic edit checks for new and ongoing clinical research studies.Additionally, responsibilities may include the design, development, implementation, and execution of data review plans to ensure the quality of collected clinical data, including oversight of multi-functional data review teams, management of electronic data received from specialty vendors (e.g., clinical laboratory, central image review), and the development of technical study documents and reports such as data transfer plans, annotated case report forms and database/data quality metrics.
Essential Dutiesinclude but are not limited to the following:· Serve as lead Data Management (DM) contact, and an active Study Team member, for assigned clinical studies.· Provide leadership and direction in management of third-party vendors such as CROs in support of timelines and data-related deliverables, and adherence to overall Thrive standards for consistency and efficiency.· Identify and troubleshoot operational problems, issues, obstacles, and barriers for study success based on metrics data, audit reports, and input from project team members and other stakeholders.· Regularly review clinical trial data within Veeva or Medidata Rave EDC to confirm data quality. Develop and execute internal procedures for data quality review and data acceptance prior to data analyses and/or database lock.· Work within and across functions to manage and optimize timelines and ensure that clinical data management deadlines are met and in high quality.· Work with database builders to develop EDC databases, Case Report Forms, edit checks, and reports, listings, and visualizations in support of protocol execution and study analyses. Conduct testing according to the UAT Plan.· Orchestrate seamless integration and functionality of additional data management technologies as needed, including randomization, trial supply management, e-consent, and patient facing clinical outcome assessment tools.· Review and provide feedback on draft protocols, Statistical Analysis Plans, CSRs and other clinical trial documents as required.· Train personnel on EDC, as needed.· Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.· Support and comply with the company’s Quality Management System policies and p

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Thrive Earlier Detection

Information Technology and Services - San Jose, United States
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