Clinical Data Management, Manager

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 to 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.   

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The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research and COVID-19 vaccine development. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I – III clinical trials in over 150 clinical sites around the world. SCHARP is seeking a Clinical Data Management, Manager. The Manager, Clinical Data Management (CDM) reporting to the Director, Data Management will manage the day to day technical and functional performance of assigned Data Management staff. The Manager, CDM is responsible for integration and implementation of critical data management processes across the organization, providing cross training to all associated staff, and serving as an expert for problem -solving data management issues.

 

The Manager, CDM oversees and coordinates Data Management projects and acts as liaison to other groups at SCHARP as well as external customers. The Manager, CDM adheres to SCHARP Standard Operating Procedures (SOPs), Work Instructions (WIs), applicable clinical trial regulations, and study confidentiality requirements. The Manager, CDM will support multi-functional teams and will support CDM through experience and knowledge as departmental subject matter expert (SME). They will maintain program/project level perspective, focus and communicate effectively as the SME on technical and functional data management issues, activities, timelines and deliverables. The Manager, CDM is responsible for the direct supervision of Data Management staff and uses independent judgment for all personnel issues including hiring, training, evaluation, discipline, and as required termination of staff. The Manager works independently in performing both routine and non-routine tasks and uses best judgment in making decisions regarding all data management, quality control, study materials, and liaison tasks. They function independently with demonstrated decision -making ability in functional and technical matters within departmentally defined procedures and practices. The Manager, CDM will have advanced knowledge of GCDMP/GCP best practices and will be responsible for training and orientation of new CDMs in collaboration with tenured CDMs. The Manager, Clinical Data Management will be accountable to set the protocol/study specific priorities and ensure all data management timelines and procedures are executed with high attention to detail, accuracy and timeliness.

• Lead the work and work product of the Clinical Data Management staff and Supervisors assigned to include; day to day technical and functional oversight, determining resource requirements, assigning team tasks, developing timelines and creating plan documentation, hiring and termination, training, employee evaluations, prioritization of projects, time and quality assurance.
• Create, review, and maintain project timelines and monitor progress of data management activities.
• Review and approve database and CRF design, and data review guidelines for new studies. Review and approve the freeze and lock of studies ensuring that all work has been fully completed, documented and stored according to Standard Operating Procedures and protocol specific requirements.
• Execute quality control activities such as preparing and carrying out internal database review, performing visual QC on data transfers.
• Act as clinical data management liaison/lead to communicate study status, timeline updates, and scope change and escalate project and departmental issues or risks to internal teams and departmental leadership.
• Identify and implement process improvements of SCHARP procedures and practices by chairing and/or participating on teams, committees and working groups.
• Develop and maintain the standardization tools and training materials.
• Work with other managers and departmental leadership to optimize practices, standards and tools to drive effective and efficient Clinical Data Management practices.
• Contribute to the functional excellence of the team by participation in continuous improvement of processes, procedures, and tools related to data management practices.
• Develop strong working relationships and maintain effective communication with employees, functional peers, research partners and SCHARP leadership.
• Actively facilitate meetings, interactions and communication among stakeholders both internal and external.
• Foster and promote the long-term development of the Clinical Data Managers and in support of great work environment.
• Provide leadership to the Data Management staff in the absence of the Director as required.

MINIMUM QUALIFICATIONS:

• Bachelor’s degree with 8+ years of experience in CDM or related field disciplines or equivalent combination of experience and education.
• 4+ years of experience in either a leadership role as a Team Leader/Manager, or a supervisory role within a CDM function in a clinical research setting.
• Demonstrated leadership, management, supervisory, and collaboration skills across functions to drive effective and efficient Clinical Data Management practices.
• Strong project management and organizational leadership experience.
• Experience in the use of commercial clinical data management systems and EDC products.
• Knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirement.
   

PREFERRED QUALIFICATIONS:

• Graduate degree in a science-related field with at least 10 years’ experience in data management with at least 5 years’ management experience in clinical research organization.
• Advanced knowledge of regulatory and clinical research business requirements.
• Experience with CDISC data standards.

 

Fred Hutch has a mandatory COVID-19 vaccine requirement, with exceptions only for approved medical or religious accommodations.
As a condition of employment, newly hired employees must provide proof of vaccination or initiate the accommodations process 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.

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.