• Data Manager

    Job ID
    14904
    Type
    Temporary Full-Time
    Company
    Hutchinson Centre Research Institute of Uganda
    Location
    UG-Kampala
    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.

     

    Global Oncology (GO), a cross-divisional program within the Director’s Office of Fred Hutchinson Cancer Research Center, has a mission to generate cancer research that has global impact, and support the development research capacity and clinical care to reduce the cancer burden in low- and middle-income countries. A cornerstone of the program is a decade-long alliance with the Uganda Cancer Institute (UCI) that advances research, capacity building, and cancer care. Fred Hutch operates in Uganda as the Hutchinson Centre Research Institute of Uganda, or HCRI-Ug.

    The HCRI-Uganda Data Manager (DM) manages data from human subjects research studies conducted by HCRI-Uganda, in partnership with the Uganda Cancer Institute (UCI), in Kampala, Uganda. At the direction of the Global Oncology Biostatistician, the DM will ensure that suitable project/study databases are built and tested, and that data is collected, entered and managed with the aim of generating the high-quality data, in compliance with regulations. Typical tasks will include developing databases, reviewing data, identifying and addressing data queries, cleaning data, and fulfilling data requests. The Data Manager will interact with the HCRI-Uganda Data Coordinators, study teams and Quality Assurance/Regulatory staff, as well as the Biostatistician and Principal Investigator, to meet the data needs of their assigned studies.

    This is a temporary, three-month position.

    Responsibilities

    • The Data Manager will personally handle data from human subjects in research studies. Therefore, s/he must be committed to maintaining respect for participants and following all applicable rules and regulations regarding human subjects research.
    • Responsible for management of human research clinical and laboratory data from assigned HCRI-Uganda research studies, to ensure the highest quality data.
    • Follow Good Clinical Data Management Practices (GCDMP) and all other program, funder, or regulatory requirements.
    • Closely follow data management procedures as described in standard operating procedures (SOPs), study specific procedures (SSPs), Data Management Plans (DMPs), and other relevant documents.
    • Design, test, validate, and implement new databases for studies as they are launched, following SOPs/SSPs and verified by the Biostatistician.
    • Assist the Biostatistician and Investigators with the design of case report forms (CRFs), with the aim of minimizing data collection errors, as requested. Report all requested modifications to study CRFs after study launch to the Biostatistician. Make approved changes to databases and CRFs.
    • Oversee activities of Data Coordinators for assigned studies: ensure that SOPs/SSPs for CRF data entry and other day-to-day procedures are followed.
    • Responsible for monitoring that data entry is occurring in as close as possible to real-time during study conduct and facilitating resolution of problems by the Data Coordinators and study clinical teams.
    • Create and apply (or supervise application by Data Coordinators) data cleaning tools (edit checks, batch edits, scripts for coding data, etc.) to study data according to SSPs/SOPs.
    • With the assistance of Data Coordinators, manage and monitor resolution of data queries.
    • Ensure that laboratory or other non-clinical data are received by the data operations staff, are complete, and are managed appropriately. Collaborate with laboratory staff to resolve queries regarding laboratory data.
    • Collaborate with the Biostatistician to review and make necessary revisions to SOPs, SSPs and DMPs, to ensure that these documents accurately reflect actual practices. Keep Biostatistician informed of changes to working procedures.
    • Create adequate documentation of data collection and management, e.g., data dictionaries, database testing, data cleaning scripts, and modifications to data and databases. Communicate these to the Biostatistician for review and management.
    • Collaborate with laboratory staff to create specimen pull-lists using clinical data, as needed.
    • Be the primary source of information about the status of study data and database, for investigators and biostatistician and others.
    • Cooperate with the Biostatistician during data audits, inspections, export, routine reports (e.g., the Data Operations Report), and data requests, as requested and in a timely manner.
    • Routinely export data to the Biostatistician or, in cooperation with the Biostatistician, to the Global Oncology Data Portal.
    • Participate or lead regular meetings of the data operations team.
    • Attend project meetings for assigned projects, as appropriate and requested by the Study Manager.
    • Other duties as assigned.

    Qualifications

    • Authorized to work in Uganda without sponsorship.
    • Relevant degree or three year diploma (IT, computer programming, biostatistics).
    • 3 years (Data Manager) or 8 years (Senior Data Manager) clinical data management experience.
    • Understanding of data management practices and tools. GCDMP knowledge. Desire to increase data management training and skills to establish a long-term career in data management.
    • MS Office literacy (Excel, Word and Outlook).
    • Proficiency in one or more data collection systems (e.g. DataFax / DFdiscover, Forte EDC, MS Access, RedCap). Ideally, some experience querying databases in SQL on any relational database system (e.g. MSSQL, MySQL and/or Access).
    • Proficiency in one or more of R, Stata, or SAS statistical analyses software.
    • Human Subjects Protection and Good Clinical Practice training.
    • Attention to detail.
    • Ability to work unsupervised, taking initiative and responsibility for actions.
    • Ability to work precisely and adhere to procedures, rules, and regulations.
    • Good trouble-shooter; recognize recurring issues and analyze their causes in order to reach a long-term solution.
    • Good English verbal and written communication skills.
    • Good time management skills; good judgement in prioritizing tasks in relation to program and project objectives.
    • Desire to continuously improve technical and other skills, and ability to self-teach.
    • A basic understanding of medical terminology and various clinical tests and procedures would be a plus.

    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 escmail@fredhutch.org or by calling 206-667-4700.

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