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. Careers Start Here.
About the Division & Research Program:
The Vaccine and Infectious Disease Division (VIDD) was established as an institute at Fred Hutch in 2007 to facilitate and enhance the Hutch's efforts in infectious disease prevention and vaccine development. The institute achieved Division status in 2010 and now has more than 50 faculty members and houses the HIV Vaccine Trials Network (HVTN) - the world's largest clinical trials network for the development and testing of an HIV vaccine.
Biostatistics, Bioinformatics, & Epidemiology (BBE) is a research program within the Vaccine and Infectious Disease Division of the Fred Hutch. With the goal being to eliminate the mortality and morbidity of infectious diseases, members of the program conduct quantitative scientific research employing biostatistics, bioinformatics, computational biology, infectious disease epidemiology, and mathematical modeling. Members of the program collaborate extensively with laboratory and clinical science colleagues both within the Hutch and provide leadership for statistical data management centers and modeling consortia worldwide.
As part of the BBE program in VIDD, 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 Senior EDC Programmer supports Clinical Data Management team members in the translation of data management plans/specifications for data entry screens, edit checks, custom functions, custom reports, data integrations, test plans and user/site accounts for clinical study builds. She/He will provide technical support as needed for additional Medidata RAVE system functionality including, but not limited to reporting, outputs, data transfer plans, and laboratory administration. The Senior EDC Programmer will work independently and be accountable to set the protocol/study specific priorities and ensure all EDC programming procedures are executed with high attention to detail, accuracy and timeliness.
The Senior EDC Programmer will support multi-functional teams and the CDM department through experience and expertise as the departmental subject matter expert (SME). 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
- Working knowledge of relational database design and FDA regulation 21 CFR Part 11
- Clinical programming experience
- Proficiency in computer skills across multiple applications
- Minimum 3 years current database programming experience designing studies and data validation programming in Medidata Rave
- Applied knowledge of Medidata suite of applications preferred (e.g. Medidata Coder, Lab Administration Module, Targeted Source Data Verification (TSDV), Safety Gateway, Patient Cloud)
- Excellent verbal and written communication skills, as well as interpersonal skills
- Experience with development, validation, and execution for regulatory submission is ideal
- Expertise with reporting tools; Business Objects, J-Review, and/or Spotfire
- Applied knowledge of CDISC/CDASH/SDTM
- Experience with external data handling of study data
- Experience with clinical dictionaries; MedDRA and WHO dictionaries
If interested, please apply online at http://track.tmpservice.com/ApplyClick.aspx?id=2360067-2647-021