Job ID REQ_96304FACILITY Rochester Regional Health LaboratoriesLOCATION Rochester, New York
As a leader within the Information Technology team, the Manager of Clinical Trials Information Systems is responsible for all technical oversight of the Clinical Trial Information Systems including evaluation, development, implementation, validation and disaster recovery. Leads, guides, coordinates and prioritizes the work for all regulatory systems. Manager of Clinical Trials Information System reports to the Director of Application Management and leads a team of Systems Analysts that support our global Clinical Trials business unit.
STATUS: Full Time
LOCATION: ACM Global Laboratories; 160 Elmgrove Road, Rochester, NY
DEPARTMENT: Information Technology
SCHEDULE: Monday - Friday
* Bachelor's Degree required; preferably in Computer Science, Information Technology, or Clinical Informatics. * 5 years of experience in Information Technology within clinical trials, clinical research, or biotechnology/life sciences required. * 3 years of experience as a lead, supervisor or manager preferred. * Knowledge and experience with Good Clinical Practices (GCP), Good Laboratory Practices (GLP), 21 CFR Part 11 and systems validation preferred. * Knowledge and experience with Laboratory Information Management Systems (LIMS) such as LabWare LIMS, StarLIMS, NuGenesis LIMS, or Nautilus LIMS preferred. * Knowledge and experience with Microsoft Access, Relational Database Development, SQL, Enterprise Systems Configuration, SQL Server Agent, Basis SSIS, SSRS, Microsoft VBA, Crystal Reports, HTML, and Java preferred.
* Project Management. Lead, guide, coordinate and prioritize organization-wide implementations, changes and development activity. Manage a wide array of projects; including but not limited to: Web Portal development, LIMS Upgrade, and LIMS Functionality. * Information Systems. Partner with global operation to provide expertise for Clinical Trial Information Systems expertise; leading activities that recognize and implement continuous process improvements to ensure market-competitiveness of ACM Global Laboratories. * Development. Develop and support application configuration; develop and promote documentation that comply with IT business and industry accepted best practices; utilize standard vendor application build, troubleshooting, and utility tools; develop departmental procedures to ensuring compliance with regulatory bodies. * Leadership.Support overall mission of the Information Technology team; develop and support a high functioning Clinical Trials Information Systems team.
EDUCATION BS (Required)
Rochester Regional Health is an Equal Opportunity / Affirmative Action Employer. Minority/Female/Disability/Veteran