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. The Center’s five scientific divisions collaborate to form a unique environment for conducting basic and applied science. Vaccine and Infectious Diseases Division (VIDD) works to eliminate or minimize the impact of globally significant infectious diseases. Within VIDD is the Statistical Center for HIV/AIDS Research & Prevention (SCHARP), which provides statistical support and data management to researchers worldwide in the fight against HIV/AIDS with active studies in the U.S., Africa, Latin America, Asia and Europe. Careers Start Here.
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).
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 will be on-site in Seattle, WA. We cannot accommodate a remote worker in this role at this time.
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, 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.
1. 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.
2. Effectively manage assigned protocol/study, establish timelines and milestones, monitor and communicate ongoing status and progress.
3. 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.
4. Participate in development of protocol/study from draft protocol to optimize collection of accurate and high-quality data.
5. Work with project sponsors, stakeholders and SCHARP team members to define project requirements, scope, risks, staffing requirements, organization and approach.
6. Act as subject matter expert for data management issues between SCHARP study teams and external domestic and international research sites for assigned studies.
7. Assist in development of Case Report Forms (CRFs) for assigned studies.
8. Assist in the design of the protocol/study specific database for assigned studies.
9. 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.
10. Perform User Acceptance Testing (UAT) for assigned studies.
11. Monitor study data to insure the quality and completeness of the data submitted by implementing quality control procedures.
12. Generate QC reports for site review and correction as well as a variety of other reports as required.
13. Evaluate study data for protocol compliance.
14. Assist in the maintenance of documentation of the study database and other related data management programs and/or applications.
15. Assist in the review of new and revised departmental SOPs and WPGs.
16. Ensure that SCHARP meets its obligations in accordance with Good Clinical Data Management Practices (GCDMP).
17. Perform other duties as assigned.
Bachelor’s degree or equivalent, preferably in a health-related or scientific discipline
2+ years’ experience in the pharmaceutical/clinical research environment as a Clinical Data Coordinator/Clinical Data Manager
EDC experience required. Working knowledge of Medidata Rave highly desirable. Demonstrated expertise in relevant clinical data management activities.
Working knowledge of ICH/GCP guidelines and FDA regulations.
Familiarity with all phases of clinical trials and ability to adapt to study requirements.
Strong verbal and written communication skills. Ability to understand and follow instructions and guidelines; able to pick up new tasks quickly; willing to ask questions when a task is not fully clear.
Ability to exercise independent judgment within generally defined practices and policies. Shows good judgment in interpreting guidelines and when to seek support.
Ability to work independently and to work efficiently under pressure.
Consistent, dedicated, versatile and able to prioritize and multi-task.
Familiarity with MS Office software and familiar with data management practices.
4+ years' experience in the pharmaceutical/clinical research environment as a Clinical Data Manager.
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.
Experience in facilitating and building consensus in an interdisciplinary team environment and able to build successful working relationships with a wide variety of collaborators.
Knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements