Fred Hutchinson Cancer Research Center
Job ID 7150
Fred Hutchinson Cancer Research Center, home of three Nobel laureates, is an independent, nonprofit research institution dedicated to the development and advancement of biomedical research to eliminate cancer and other potentially fatal diseases. Recognized internationally for our pioneering work in bone-marrow transplantation, the five scientific divisions at Fred Hutch collaborate to form a unique environment for conducting basic and applied science. Fred Hutch, in collaboration with its clinical and research partners, the University of Washington and Seattle Children’s, is the only National Cancer Institute-designated comprehensive cancer center in the Pacific Northwest. Join us and make a difference!
The Statistical Center for HIV/AIDS Research & Prevention (SCHARP) provides statistical collaboration to infectious disease researchers around the world and conducts a complementary program of statistical methodology, and mathematical modeling research. SCHARP also collects, manages, and analyzes data from clinical trials and epidemiological studies dedicated to the elimination of infectious disease as a threat to human health. Current projects include studies to evaluate and implement prevention strategies for HIV, tuberculosis, polio, malaria and other globally important pathogens.
The Clinical Data Manager III (CDM III) leads and monitors the collection, processing, data entry and quality control of study data. She/He is responsible for effectively managing timelines, quality and delivery of data for assigned projects that are in support of clinical trials research. She/He develops and maintains successful working relationships with their team and specific research sites to ensure and maintain data integrity and quality. The CDM III work within a network/study/protocol team to ensure that SCHARP meets its statistical and data management center (SDMC) deliverables on time.
The CDM III leads the SCHARP project/study team coordinating with both internal and external partners and collaborators to ensure the relevant data are collected to meet the needs of the project or research objectives. S/he uses best practices for project management. The CDM III is the primary SCHARP contact for protocol/project implementation, operation, and closeout phases and is responsible for communication, documentation, and providing training on data collection and management activities for domestic and international research sites.
S/he functions with minimal supervision with demonstrated decision-making ability in operational and technical matters within defined procedures and practices. The CDM III will have advanced knowledge of data management operations best practices and network-specific activities. S/he 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. S/he will be coordinating larger, more complex studies and/or a larger volume of studies with minimal assistance.
- Coordinate Safety/Study Monitoring Committees or Data and Safety Monitoring Board review process, as applicable.
- Prepare status reports and keep study/project sponsors, team, SCHARP management, and stakeholders informed of status and issues.
- Ensure that SCHARP meets its obligations in accordance with Good Clinical Data Management Practices (GCDMP).
- Perform other duties as assigned.
- Assist in the review of new and revised departmental SOPs and WPGs.
- Assist in the maintenance of documentation of the study database and other related data management programs and/or applications.
- Evaluate study data for protocol compliance.
- Generate QC reports for site review and correction as well as a variety of other reports as required.
- Monitor study data to insure the quality and completeness of the data submitted by implementing quality control procedures.
- Perform User Acceptance Testing (UAT) 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.
- Assist in the design of the protocol/study specific database for assigned studies.
- Assist in development of Case Report Forms (CRFs) for assigned studies.
- Act as subject matter expert for data management issues between SCHARP study teams and external domestic and international research sites for assigned studies.
- Work with project sponsors, stakeholders and SCHARP team members to define project requirements, scope, risks, staffing requirements, organization and approach.
- Participate in development of protocol/study from draft protocol to optimize collection of accurate and high-quality data.
- 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.
- Effectively manage assigned protocol/study, establish timelines and milestones, monitor and communicate ongoing status and progress.
- 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.
- Coordinate approved requests for changes to scope of work according to defined change control procedures.
- Close studies/projects ensuring that all project work has been fully completed, documented and stored.
- Contribute to ongoing development of SCHARP procedures and practices by participating in committees and working groups.
- Assist in the development and maintenance of standardization tools and training materials for the Data Operations Unit.
- Act as a resource providing guidance on best practices and provide subject matter expertise on network-specific questions.
- Perform other duties as assigned.
- 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 highly desirable. Demonstrated expertise in relevant clinical data management activities. Experience using SAS and relational databases (e.g. MS SQL Server, MS Access, or Oracle)
- Experience in clinical trial and regulated research settings desired. Experience with managing immunology, infectious disease and/or virology research projects desired. Prior experience in HIV or infectious diseases clinical trial operation management and/or protocol development preferred.
- Familiarity with all phases of clinical trials and ability to adapt to study requirements.
- 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 written and oral communication skills.
- Proficient with MS Office software and familiar with data management practices. Familiarity with project management software desirable.
- Ability to work independently and to work efficiently under pressure.
- Consistent, dedicated, versatile and able to prioritize and multi-task.
- Knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements