Overview

Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.

With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world's leading cancer, infectious disease and biomedical research centers. 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 to the world's deadliest diseases and make life beyond cancer a reality.

At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. These values are grounded in and expressed through the principles of diversity, equity and inclusion. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an anti-racist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, anti-racism and inclusion.

We are actively expanding our Clinical Research Support (CRS) team to support Principal Investigators (PIs) and research study teams who are focused on mission-critical clinical trial programs. The Senior Data Manager, IIT Program is responsible for strategy and operational management of all aspects of data capture and management for investigator-initiated trials (IITs) in our oncology clinical trials portfolio. The IIT trial portfolio includes multi-site and single-site investigator-initiated IND trials and non-IND studies.

The role manages the lifecycle of IITs from a data perspective from eCRF and database design, to build, testing, data management, quality control (QC), amendments, and closeout. The incumbent will develop systems and processes for managing each aspect of this lifecycle and drive progress with investigators, research teams and various stakeholders engaged in IITs from initiation to closeout.

At Fred Hutchinson Cancer Center, all employees are expected to demonstrate a commitment to our values of collaboration, compassion, determination, excellence, innovation, integrity, and respect.

Responsibilities

• Responsible for designing & continuously improving data management processes for IITs from initiation to closeout.
• Directly oversee a team of data coordinators who perform data entry, data QC, and data reporting activities.
• In collaboration with research disease groups, administer data management strategies that meet the needs of each program while adhering to institutional standards.
  • Serve as subject matter expert for data management best practices and industry trends.
• Collaborate closely with investigators, study teams, and biostatisticians to translate protocol requirements into eCRFs, ensuring all critical data points are captured.
  • Lead design, development, and user acceptance testing (UAT) for eCRFs that are user friendly, and support data quality.
  • Lead database development, configuration, and testing ensuring alignment with industry data standards.
• Oversee the development and maintenance of data entry and management guidelines, standards, Standard Operating Procedures (SOPs), and work instructions to ensure data is accurate, complete, and compliant with regulatory requirements.
  • Generate eCRF Completion Guidelines and Data Management Plans specific to each project's requirements, addressing coding methodologies, data transfer protocols, and data flow from entry to analysis.
• Develop and implement data QC processes to ensure data quality, completeness, accuracy, and timeliness of entry.
  • Generate queries and oversee remediation of data discrepancies and data-related issues.
• Lead preparation of data sets and reports to assist in data review and study maintenance. Ensure validity of clinical trial data and perform database finalization for interim or final data analysis.
• Assess, recommend, and implement electronic data capture (EDC) systems to support the data capture needs across the Consortium's study portfolio.
• Recommend institutional data policy that outlines EDC requirements for IITs.
• Manage external contractors and vendors ensuring deliverables meet quality measures and timelines. Oversee review and negotiation of data management vendor contracts.
• Perform other related duties as assigned.
• Other duties as assigned.

Qualifications

MINIMUM QUALIFICATIONS:

• Bachelor's degree or equivalent relevant experience.
• Minimum of five (5) years of experience in clinical research operations preferably oncology clinical trial data management with a focus on eCRF design and database building.
• Minimum of two (2) years of supervisory or vendor management experience .

PREFERRED QUALIFICATIONS:

• Clinical research related certification.
• Knowledge of CTMS and EDC systems.
• Knowledge of EHR systems.
• Solid background in clinical database standards and experience building databases from clinical protocols.
• Outstanding attention to detail and strong analytical skills.
• Critical thinking and problem-solving to ensure unforeseen issues are handled appropriately and resolved in a timely fashion.
• Experience working in multi-disciplinary teams.
• Knowledge of applicable local, state, and federal regulations and guidelines for clinical research.
• Mentoring/training staff and/or teams.
• Forecasting and meeting deadlines.
• Communicating with all levels of a research organization.
• Team building and management.
• Strong verbal and written communication skills.
• Excellent computer skills including ability to use wide variety of software packages for research data management.

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.

The annual base salary range for this position is from $124,488 to $196,747, and pay offered will be based on experience and qualifications. Fred Hutchinson Cancer Center offers employees a comprehensive benefits package designed to enhance health, well-being, and financial security. Benefits include medical/vision, dental, flexible spending accounts, life, disability, retirement, family life support, employee assistance program, onsite health clinic, tuition reimbursement, paid vacation (12-22 days per year), paid sick leave (12-25 days per year), paid holidays (13 days per year), paid parental leave (up to 4 weeks), and partially paid sabbatical leave (up to 6 months).

Our Commitment to Diversity