Statistical Center for HIV/AIDS Research and Prevention (SCHARP) is seeking a EDC Programmer to support multi-functional teams and the CDM department through experience and expertise as the departmental subject matter expert (SME). She/He will provide technical support as needed for Medidata RAVE system functionality including, but not limited to reporting, outputs, data transfer plans, and laboratory administration. They will maintain program/project level perspective, focus and communicate effectively as the SME on technical and functional EDC programming and data management issues, activities, timelines and deliverables.
Manages, performs or delegates:
- Database design specification in consultation with Data Management, Lab Data Management, Clinical and Statistical Programming, Clinical Coding, and Safety
- Collaborate on/update global library as appropriate according to best practices and new standards
- Designs/creates and tests clinical databases including forms, folders, matrices, data dictionaries, unit dictionaries, edit checks, derivations, custom functions, standard and custom reports
- Validates specification to development through leading team review, co-programmer review, and User Acceptance Testing
- Perform User and Site Administration to include site set up and assignment of roles, permissions and eLearning requirements
- Verifies completeness of study deliverables prior to release
- Performs peer review for the studies built by other programmers
- Maintains all required study documentation
- Responsible for the development, maintenance, and compliance of database builds and EDC standards in support of clinical studies including, but not limited to, Global Library, Edit Checks, CRF modules and Standard/Custom Reports.
- Serves as a contact/resource for Process/Standards development and implementation including best practices in an effort to improve quality and streamline database build and data cleaning efforts.
- Provides EDC technical support to facilitate study timelines and deliverables.
- Manages timely-quality deliverables for the study teams for assigned protocol/study(s)
- Conduct training on EDC database use to support internal users.
- Consults and provides input into system validation efforts including tool maintenance activities.
- Functions as an EDC Subject Matter Expert (SME) providing guidance and best practice recommendations to Data Management, operations teams and other stakeholders.
- As SME is responsible to provide escalation of study specific functional issues, tool/vendor issues, testing and validation needs, enhancement requirements, custom functions and/or custom reporting.
- Serves as a subject matter expert for escalation and provides expertise for problem-solving with clinical database technology, capabilities and functionality.
- Assist in all areas of DM process improvements and Standards (SDTM / CDASH).
- Support development and review of SOPs, and Work Guidelines to promote consistency.
- Identify additional opportunities for standardization and departmental efficiency.
- Facilitate change management within the Clinical Programming Group to assist in the export and provision of study data where required
- Provide technical assistance and training to technical / non-technical personnel.
- BA / BS degree in Computer Science/Information Technology or Life Sciences
- Clinical programming experience is required.
- Proficiency in computer skills across multiple applications.
- Minimum 3 years current database programming experience designing studies and data validation programming in Medidata Rave required.
- Applied knowledge of Medidata suite of applications preferred (e.g. Medidata Coder, Lab Administration Module, Targeted Source Data Verification (TSDV), Safety Gateway, Patient Cloud).
- Experience with development, validation, and execution for regulatory submission is ideal
- Expertise with reporting tools; Business Objects, J-Review, and/or Spotfire are preferred
- Applied knowledge of CDISC/CDASH/SDTM preferred
- Experience with external data handling of study data preferred
- Experience with clinical dictionaries; MedDRA and WHO dictionaries are preferred
- Excellent verbal and written communication skills, as well as interpersonal skills are required.
- Has a working knowledge of relational database design and FDA regulation 21 CFR Part 11
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 and largest 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.
The Statistical Center for HIV/AIDS Research & Prevention (SCHARP) at Fred Hutch provides statistical collaboration to infectious disease researchers around the world. SCHARP collects, manages, and analyzes data from clinical trials and epidemiological studies dedicated to the elimination of infectious disease as a threat to human health.
SCHARP provides statistical and data management services to:
- The HIV Vaccine Trials Network (HVTN) is an international collaboration of scientists and experts testing preventive vaccines against HIV/AIDS.
- The HIV Prevention Trials Network (HPTN) is a worldwide collaborative clinical trials network that develops and tests the safety and efficacy of primarily non-vaccine interventions designed to prevent the transmission of HIV.
- The Microbicides Trials Network (MTN) is collaboration among researchers worldwide who conduct clinical trials using microbial preventions.
- The Collaboration for AIDS Vaccine Discovery (CAVD) is an international network of scientists and experts dedicated to designing a variety of novel HIV vaccine candidates and advancing the most promising candidates to clinical trials.
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