How to Apply
A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.
The Statistical Analysis of Biomedical and Educational Research [SABER] unit is the Data Coordinating Center for several multi-center clinical trials and observational studies. Responsibilities include monitoring data flow in multiple databases and ensuring collected data are complete, current and valid.
Responsible for data management for multiple clinical trials and study databases as outlined below.
Project Start-up: Work collaboratively and independently to develop electronic entry screens, databases and supporting documentation; testing and implementation of electronic data capture, to meet the needs of studies. This may also include analysis of existing data for migration. Assisting in project management and planning for all aspects of data collection and data processing for research studies. Responsible for creation, testing and implementation of electronic data checks, listings and Data Management Plan, following standard practice guidelines. Train study participants in the use of electronic data capture and data discrepancy systems.
Study Conduct: Revisions to data entry screens, data checks, Data Management Plans and reporting requirements. Review and resolution of data discrepancies using electronic data check systems. Responsible for DSMB reporting, database audits, and standard and study-specific reporting including form tracking/status reports, enforcing defined operational policies and procedures for data management and support of end users.
Study Closure: Perform database close and locking procedures, and procedures for archiving research databases. Responsible for the finalizing and archival of all data management study data and documentation.
Other responsibilities include: collaboration on the creation and review of Standard Operating Procedures, working with the SABER programming staff assisting in the development of functional requirements for applications used, creation and execution of test scripts for user acceptance. Attend and actively participate in functional group and research teams meetings; provide updates and participate in revisions and/or issue resolution.
- Bachelor's degree or Associate’s degree with 2 years equivalent experience and training.
- Experience (5+) years supporting clinical research data management in a regulatory compliant environment (HIPAA, GxP, 21CRF Part 11, etc) is preferred.
- Knowledge/experience using SQL and XML is preferred.
- Experience with EDC software is preferred.
- Experience with and knowledge of relational databases.
- Proficiency with data editing/cleaning and quality control procedures.
- Ability to work as a team member and independently; perform effectively in a complex and dynamic environment; analyze problems in a logical and systematic manner.
- Effective oral, written and interpersonal communication skills.
- Ability to handle multiple long term projects simultaneously and manage time effectively.
- Accuracy and attention to detail is required.
- Demonstrated ability and experience with Microsoft Excel, Microsoft Word and Adobe is required.
We are seeking an experienced and dynamic staff (leader/member) with a commitment to contributing to a diverse, equitable and inclusive environment for all members of our community.
The University of Michigan conducts background checks on all job candidates upon acceptance of a contingent offer and may use a third party administrator to conduct background checks. Background checks will be performed in compliance with the Fair Credit Reporting Act.
U-M EEO/AA Statement
The University of Michigan is an equal opportunity/affirmative action employer.