Clinical Data Manager I-II

Job ID
22163
Type
Regular Full-Time
Company
Fred Hutchinson Cancer Research Center
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 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.   


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 Manager I-II.

 

The Clinical Data Manager I (CDM I) supports and monitors the collection, processing, data entry and quality control of study data. The CDM I works within a network/study/protocol team to support the policies and goals of each project assigned. The Clinical Data Manager II (CDM II) leads and monitors the collection, processing, data entry and quality control of study data. 

 

The CDM II works within a network/study/protocol team to ensure that SCHARP meets its statistical and data management center (SDMC) deliverables on time. 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. 
 
Applying GCP and GCDMP principles, the CDM 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 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 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 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 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

Level I

  • 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 or protocol work, 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 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.
  • May 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.
  • Assist in development of Case Report Forms (CRFs) for assigned studies.
  • Assist in the design of the protocol/study specific database for assigned studies.
  • Assist in 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.
  • Assist in the maintenance of documentation of the study database and other related data management programs and/or applications.
  • Monitor study data 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.
  • May prepare status reports and keep study/project sponsors, team, SCHARP management, and stakeholders informed of status and issues.
  • May coordinate Safety/Study Monitoring Committee review process, as applicable.
  • Assist or may lead approved requests for changes to scope of work according to defined change control procedures.
  • Assist or may lead the closure activities for studies/projects ensuring that all project work has been fully completed and documented.
  • Support creation and maintenance of Trial Master File (TMF).
  • Assist in the review of new and revised departmental SOPs and WIs.
  • Ensure that SCHARP meets its obligations in accordance with Good Clinical Data Management Practices (GCDMP).
  • Perform other duties as assigned.

Level II

  • All Level I responsibilities
  • 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.
  • Leads the maintenance of documentation of the study database and other related data management programs and/or applications.
  • 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
  • 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.
  • Level I:
    • 2+ years’ experience in the pharmaceutical/clinical research environment as Clinical Data Coordinator/Clinical Data Manager.
  • Level II:
    • 4+ years’ experience in the pharmaceutical/clinical research environment as a Clinical Data Manager.
  • EDC experience preferred.
  • 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.
  • Level I:
    • Ability to exercise independent judgment within generally defined practices and policies. Shows good judgment in interpreting guidelines and when to seek support.
    • Demonstrated problem-solving skills. Self-motivated and able to work independently using strong organizational, project and time management skills.Strong verbal and written communication skills.
    • Proficient with MS Office software.
  • Level II:
    • Experience in clinical trial and regulated research settings.

PREFERRED QUALIFICATIONS:

 

  • Working knowledge of Medidata Rave highly desirable
  • Level II:
    • Prior experience in HIV or infectious diseases clinical trial operation management and/or protocol development preferred.
  • Experience with managing immunology, infectious disease and/or virology research projects desired.
  • Familiarity with project management software desirable.

 

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.  #ZR

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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