Cancer Center Jobs

Assistant Director, Clinical Trial Data Management

Fred Hutchinson Cancer Research Center

February 3, 2022
Assisstant Director, Clinical Trial Data Management
Job Id: 21616

Please apply at: Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance - Asst Director, Clinical Trial Data Management in Seattle, Washington | Careers at Fred Hutchinson Cancer Research Center (icims.com)
 
Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

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 Assistant Director, Clinical Trial Data Management is primarily responsible for oversight, 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

Provide administrative direction and implementation of clinical trial data management functions, policies, and procedures. 
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.  
Oversee teams of data coordinator staff and lead rapid expansion of teams. 
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. 
Provides input into database builds, validation processes and case report form development. 
Compile and evaluate research resource utilization and allocation. Make recommendations and oversee changes in operations as necessary. Develop systems for continuous monitoring. 
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. 
Liaison with all levels of administration, faculty, and outside organizations to coordinate data operations, and accomplish program goals. 
Serve as subject matter expert and data management best practices and industry trends 
Performs other related duties as assigned. 

Qualifications

MINIMUM QUALIFICATIONS:

Bachelor's degree  
Minimum of 5 years of data management experience, preferably clinical trial and oncology data. 
At least 2 years professional experience managing personnel. Strong leadership skills are required to lead team through periods of growth, change and time pressure. The ideal candidate will have a demonstrated ability to: 

manage a diverse team, think creatively and globally, project future needs, and be attuned to the day-to-day division operations  
effectively lead individual teams as well as act collaboratively across an organization

Develop and document procedures through strong project management and business analysis skills, methodologies and best practices with demonstrated ability to standardize operations and processes 
Analyze data and apply an analytical framework to decision making 
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 

 
PREFERRED QUALIFICATIONS:

Advanced degree preferred 
Previous experience managing data operations for oncology clinical trials 
Experience in design and/or build of case report forms 

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 HR Operations at [email protected] or by calling 206-667-4700.