Senior Manager, Clinical Trial Data Management

Job ID
22594
Type
Regular Full-Time
Location
US-WA-Seattle
Category
Clinical Research Support Services

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit, unified adult cancer care and research center that is clinically integrated with UW Medicine, a world leader in clinical care, research and learning. The first National Cancer Institute-designated cancer center in the Pacific Northwest, Fred Hutch’s global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy, and COVID-19 vaccines has confirmed our reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Based in Seattle, Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy, and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures for the world’s deadliest diseases and make life beyond cancer a reality.

 

At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion.   

 

We are actively expanding our central data team to support Principal Investigators (PIs) and research study teams who are focused on mission-critical clinical trials programs. The Senior Manager, Clinical Trial Data Management is primarily responsible for strategy, administration, training, and coordination of data management for our oncology clinical trials portfolio.  The trial portfolios include multi-site investigator-initiated IND trials, industry trials, and single-site investigator-initiated trials. 

Responsibilities

  • Define strategy and roadmap for how to leverage key systems such as Epic Systems, Advarra CTMS, Advarra EDC, REDCap, & Florence eReg for effective data management; collaborate with partner teams such as CTMS and central regulatory on strategy development and implementation.
  • Oversee the development and maintenance of central team Standard Operating Procedures (SOPs) and work instructions related to data management activities for all trial types.
  • Oversee teams of data coordinator staff.
  • Define standard approach for data management for Investigator Initiated Trials (IITs) and lead implementation approach for assigned IIT projects:
    • Assist in the development of study protocol as it relates to data operations, updating and revising protocol as required.
    • Lead authoring and maintaining of project start-up documents including, but not limited to: eCRFs, eCRF Completion Guidelines, Data Management Plan, Edit Check Specifications.
    • Lead design, implementation and user acceptance testing for assigned projects.
    • Lead preparation of all data cleaning and data status documentation; including, but not limited to metric reports, custom reports, data review listings, reconciliation reports, clean patient tracker, etc.
    • Perform quality control audits of data operations activities and coordinate quality control evaluations from outside organizations or funding sources.
    • Document quality control audit results in formal report form for presentation to and discussion with appropriate authority and/or funding source.
    • Coordinate and oversee the investigation and resolution of data discrepancies.
  • In collaboration with research disease groups, administer data management strategies that meet the needs of each program while adhering to institutional standards.
  • Provide oversight for training of new recruits and existing staff; Educate team members as needed regarding data management processes, workflow, and data standards that may have direct impact on their work.
  • Formulate short-term and long-term strategies to improve data management efficiencies.
  • Ensure projects are conducted in compliance with applicable regulations and operating procedures.
  • Establish and implement routine data audits to ensure quality and completeness of the data submitted.
  • Implement standardization of data management to complete data submissions on schedule and according to quality standards and study requirements.
  • Serve as subject matter expert and data management best practices and industry trends.
  • Perform other related duties as assigned.

Qualifications

  • Bachelor's degree or additional relevant experience required.
  • Minimum of 5 years of clinical trial data management experience preferably with oncology data.
  • At least 1-year professional experience managing personnel.
  • Experience in design and/or build of case report forms.
  • Sustained, proven ability to think analytically, problem solve and use independent judgment.
  • Excellent communication (written and oral), customer service, collaboration, problem solving and interpersonal skills.
  • Excellent interpersonal skills with the ability to build strong relationships with a diverse group of stakeholders, including technical and non-technical personnel at various levels in the organization.
  • Knowledge of FDA regulations, GCP guidelines, and other applicable federal regulations.
  • Knowledge of CTMS and EDC systems.
  • Knowledge of EHR systems.
  • Excellent computer skills including ability to use wide variety of software packages for research data management.

 

In addition to job duties at Fred Hutch, this position also requires access to Seattle Cancer Care Alliance, which requires COVID-19 vaccination without exceptions.
Accordingly, as a condition of employment for this Fred Hutch position, newly hired employees must provide proof of vaccination before their first day of employment.

 

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.

Our Commitment to Diversity

We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to our Employee Services Center at hrops@fredhutch.org or by calling 206-667-4700.

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