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.

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. 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 Manager I/II.

The Clinical Data Manager I/II (CDM I/II) leads and monitors the collection, processing, data entry and quality control of study data. They are responsible for effectively managing timelines, quality and delivery of data for assigned projects that are in support of clinical trials research. They develop and maintain successful working relationships with their team and specific research sites to ensure and maintain data integrity and quality. The CDM I/II works within a network/study/protocol team to ensure that SCHARP meets its statistical and data management center (SDMC) deliverables on time.

Applying GCP and GCDMP principles, the CDM I/II manages the protocol/study specific tasks including coordinating clinical and laboratory database deliverables, working with collaborators on data content requirements, leading data quality and closeout activities throughout the data management lifecycle.

The CDM I/II adheres to SCHARP Standard Operating Procedures (SOPs), Work Instructions (WIs), applicable clinical trial regulations, and study confidentiality requirements and functions with moderate supervision in operational and technical matters within defined procedures and practices.

The CDM I/II will manage or support study/protocols with moderate supervision from departmental leadership and will use judgment in making decisions regarding routine data management, quality control and liaison tasks. The CDM II is the primary SCHARP contact for study/protocol specific implementation, operation, and closeout phases and is responsible study communication, documentation, and providing training on data collection and management activities for domestic and international research sites for assigned protocol/study(s).

The CDM I/II is a member of the protocol/study team coordinating with both internal and external partners and collaborators to ensure the relevant data are collected and cleaned to meet the needs of the protocol/study and research objectives.

Responsibilities

Responsibilities

• Manage study/project implementation including but not limited to leading SCHARP team members through CRF, lab, and other data collection processes, reporting and analysis requirements, study/project documentation and training.
• Effectively manage assigned protocol/study, establish timelines and milestones, monitor and communicate ongoing status and progress.
• Act as subject matter expert for data management issues between SCHARP study teams and external domestic and international research sites for assigned studies, including conducting site trainings, development of study specific procedures (SSPs) and other protocol-related data management materials.
• Ensure rapid resolution of issues/problems using appropriate internal and/or external resources. Track and manage issues escalating to the appropriate level in a timely manner.
• Participate in development of protocol/study from draft protocol to optimize collection of accurate and high-quality data.Work with project sponsors, stakeholders and SCHARP team members to define project requirements, scope, risks, organization and approach.
• Leads the development of Case Report Forms (CRFs) for assigned studies.
• Leads the design of the protocol/study specific database for assigned studies.
• Leads the maintenance of the study database including routine revisions or additions to include the design and/or modification of routine and existing study database edit check programs for assigned studies.
• Perform User Acceptance Testing (UAT) for assigned studies.
• Leads the maintenance of documentation of the study database and other related data management programs and/or applications.
• Monitor study data for protocol compliance to ensure the quality and completeness of the data submitted by implementing quality control procedures.
• Generate QC reports and/or data listings for site review and correction as well as other data cleaning reports as required.
• Prepare status reports and keep study/project sponsors, team, SCHARP management, and stakeholders informed of status and issues.
• Lead and manage approved requests for changes to scope of work according to defined change control procedures.
• Coordinate Safety/Study Monitoring Committees or Data and Safety Monitoring Board review process, as applicable.
• Close studies/projects ensuring that all project work has been fully completed, documented and stored.
• Create and maintain the Trial Master File (TMF).
• May create, revise and/or review new and revised departmental SOPs and WIs.
• Ensure that SCHARP meets its obligations in accordance with Good Clinical Data Management Practices (GCDMP).
• May contribute to ongoing development of SCHARP procedures and practices by participating in committees and working groups.
• May mentor Clinical Data Coordinators and/or a Clinical Data Manager I.
• Perform other duties as assigned.

Qualifications

Minimum Qualifications

• Bachelor's degree or equivalent, preferably in a health-related or scientific discipline.
• CDM I: 2+ years' experience in the pharmaceutical/clinical research environment as a Clinical Data Coordinator or Clinical Data Manager.
• CDM II: 4+ years' experience in the pharmaceutical/clinical research environment as a Clinical Data Manager.
• EDC experience required.
• Demonstrated expertise in relevant clinical data management activities.
• Knowledge of clinical research, FDA & ICH, GCP, GCDMP, SDTM and related regulatory requirements.
• Familiarity with all phases of clinical trials and ability to adapt to study requirements.
• Experience in clinical trial and regulated research settings.
• Demonstrated problem-solving skills. Self-motivated and able to work independently using strong organizational, project and time management skills.
• Strong written and oral communication skills.
• Proficient with MS Office software.

Preferred Qualifications

• Working knowledge of Medidata Rave highly desirable.
• Prior experience in HIV or infectious diseases clinical trial operation management and/or protocol development preferred.

Fred Hutchinson Cancer Center 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, prior to their first day of employment: Provide proof of being fully vaccinated against COVID-19 ; ORInitiate the accommodations process to request a religious or medical accommodation (medical accommodations require a healthcare provider's certification).

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 the I position is from $72,194 to $108,292 and pay offered will be based on experience and qualifications.

The annual base salary range for the II position is from $81,979 to $122,969 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

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.