Lead Data Analyst​/EDC System Administrator Clinical Research Informatics

Lead Data Analyst / EDC System Administrator – Clinical Research Informatics

Location:

US-OR-Portland

Requisition :
Position Type:
Regular Full-Time
Posting Salary Range: $67,454.40 – $ per year (based on education, experience and internal equity)

The mission of Knight Clinical Research Quality & Administration (CRQA) is to foster a supportive environment conducive to achieving the Knight's clinical research mission. CRQA provides a central location for policies, procedures, and systems to aid investigators and research groups with respect to trial development, execution, and oversight.

• EDC Application Builds
  • Oversees and directly supports the development, construction and maintenance of trial-specific electronic data capture (EDC) applications for OHSU investigators conducting cancer-related clinical research within established Knight approved systems (e.g. Advarra, REDCap).
  • Serves as a subject matter expert (SME) for EDC systems and provides guidance to stakeholders on best practices related to data management.
  • Maintains project management tracking for EDC build projects in support of program metrics and to ensure clear communication to impacted stakeholders.
• EDC Application System Administration and Team Lead
  • Oversees and directly contributes to EDC system administration and maintenance. For example, conducts routine SOP reviews and updates, risk assessments associated with system upgrades, and leads the Change Team in evaluating and managing other necessary system changes.
  • Maintains User Management database for all EDC users in keeping with 21 CFR part 11 compliance.
  • Maintains Project Change Request database to ensure post live requests and revision timelines.
  • Assigns EDC build and/or program related tasks to other informatics staff in support of the above.
• Data Governance and Reporting
  • Contributes to the maintenance of a system of data governance and reporting within the Knight Cancer Institute as it relates to electronic data capture for protocol-driven clinical research studies and data within the clinical trials management system (CTMS). A system of data governance provides access, standardization, and definitions around critical data needed for the Knight Cancer Institute and is vital to ensure consistency, accuracy and overall trust in the data compiled for reporting and publication purposes.
  • Leveraging data governance infrastructure, serves as a subject matter expert for the design and maintenance of reporting solutions to extract and present data to meet analytic requirements.
• Overall
  • Independently manages workload within CRQA service level understanding timelines and job description expectations.
  • Participates in and contributes to team meetings and huddles, Knight-wide meetings, inter-departmental collaborations, process improvement initiatives, mentorship, and professional development activities as applicable to the role.
  • Stays up-to-date on OHSU-wide updates, fulfills all OHSU requirements necessary for ongoing employment, and otherwise is welcome to engage in OHSU-wide initiatives, within reasonable limits.
  • Provides back-up support to other CRQA positions/activities as needed for coverage purposes, understanding this may mean a temporary shift in FTE distribution of duties.

Education & Experience:

• PhD Degree OR
• Master's Degree AND 4 years of relevant experience OR
• Bachelor's Degree AND 6 years of relevant experience.

Relevant Experience Should Include:

• Direct bioinformatics, relational database, Electronic Data Capture (EDC) design/build, and/or clinical research coordination/management experience.
• Two years of direct experience using an Enterprise BI tool (e.g., Cognos, Tableau, Power BI) and/or direct experience designing/building clinical research related Electronic Data Capture (EDC) databases.

Knowledge, Skills & Abilities:

• Strong knowledge of clinical research and Good Clinical Practice (GCP).
• Strong knowledge of database/data capture applications; i.e. design, construction, use and management.
• Strong knowledge of reporting functionality; i.e. requirements gathering, documentation, database query development, data table relationships,…