Clinical Data Manager II-III

Job ID
19151
Type
Temporary Full-Time
Company
Fred Hutchinson Cancer Research Center
Location
US-WA-Seattle
Category
Clinical Research Support Services

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.

 


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 (CDM) to join their group. The CDM 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 works within a network/study/protocol team to support the policies and goals of each project assigned. 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 Practice Guidelines (WPGs), applicable clinical trial regulations, and study confidentiality requirements and functions with moderate supervision in operational and technical matters within defined procedures and practices.

 

PLEASE NOTE: This position is temporary, 6 months. At this time we do not anticipate conversion to regular employee at the end of the contract period. 

Responsibilities

The Clinical Data Manager (CDM) will manage study/protocols with moderate supervision from senior staff and/or 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 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.


For the more experienced CDM, they may participate in training and orientation of new CDMs when appropriate, and may serve as a CDM mentor. Assignment of projects/trials is commensurate with previous experience and can be assigned across scientific areas or study phases. They will be coordinating larger, more complex studies and/or a larger volume of studies with minimal assistance.

  • Manages 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
  • 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, staffing requirements, organization and approach
  • Act as subject matter expert for data management issues between SCHARP study teams and external domestic and international research sites for assigned studies
  • 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
  • Monitor study data to insure the quality and completeness of the data submitted by implementing quality control procedures
  • Generate QC reports for site review and correction as well as a variety of other reports as required
  • Evaluate study data for protocol compliance
  • Assist in the maintenance of documentation of the study database and other related data management programs and/or applications
  • Assist in the review of new and revised departmental SOPs and WPGs
  • Ensure that SCHARP meets its obligations in accordance with Good Clinical Data Management Practices (GCDMP)
  • Perform other duties as assigned

Qualifications

Minimum qualifications

 

Level II

  • Bachelor’s degree or equivalent, preferably in a health-related or scientific discipline
  • 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

 

Level III

  • Bachelor’s degree or equivalent, preferably in a health-related or scientific discipline
  • 6+ years’ experience in the pharmaceutical/clinical research environment as Clinical Data Manager
  • EDC experience required. Working knowledge of Medidata Rave 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
  • Experience in facilitating and building consensus in an interdisciplinary team environment and able to build successful working relationships with a wide variety of collaborators
  • Strong verbal and written communication skills
  • Proficient with MS Office software

 

 

Preferred qualifications

Level II

  • Working knowledge of Medidata Rave highly desirable
  • 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

 

Level III

  • Experience with managing immunology, infectious disease and/or virology research projects highly desired
  • Prior experience in HIV or infectious diseases clinical trial operation management and/or protocol development highly preferred
  • Experience using SAS and relational databases (e.g. MS SQL Server, MS Access, or Oracle) preferred
  • Familiarity with project management software desirable

 


A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and anti-racism in your career or that will be made through 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 Employee Services Center at hrops@fredhutch.org or by calling 206-667-4700.

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