SABER Project Manager

The University of Michigan's Statistical Analysis of Biomedical and Educational Research (SABER) unit is a data coordinating center for multi-center clinical trials and observational studies. The SABER Project Manager provides overall coordination and operational oversight for assigned studies, manages stakeholder communications and timelines, and supports study operations, data quality, monitoring, regulatory compliance, and safety activities.

Responsibilities:

• Serve as the primary project manager for assigned studies, providing overall coordination and operational oversight
• Lead study meetings, including development of agendas, documentation of meeting minutes, tracking of action items, and follow-up on key decisions
• Maintain study timelines, milestones, risk logs, and issue trackers to support successful study execution
• Facilitate communication and collaboration among DCC functional teams, clinical sites, investigators, study leadership, monitors, vendors, and external stakeholders
• Provide regular study status updates and escalate operational risks or issues as appropriate
• Support study startup, conduct, and close-out operational activities
• Develop, maintain, and distribute study-specific operational documents, templates, manuals, and guidance materials
• Coordinate site startup activities, including training and study activation activities
• Track study enrollment, site performance, operational milestones, and study deliverables
• Collaborate with study teams to identify and resolve operational challenges affecting study conduct
• Collaborate with data management teams on electronic case report form (eCRF) design, database testing, validation, and implementation activities
• Assist with clinical monitoring activities
• Review data quality metrics and reports to identify trends, discrepancies, and potential data issues
• Coordinate data query management activities and facilitate timely resolution of data discrepancies with study sites
• Coordinate adverse event (AE) and serious adverse event (SAE) reporting and tracking activities in accordance with study and regulatory requirements
• Coordinate Data and Safety Monitoring Board (DSMB) activities, including meeting logistics, preparation of DSMB reports, safety summaries, and study progress reports, as well as documentation and follow-up on DSMB recommendations and action items
• Help to ensure study documentation remains complete and inspection-ready
• Monitor compliance with study protocols, monitoring plans, Good Clinical Practice (GCP) requirements, institutional policies, and applicable federal regulations

Requirements:

• SOCRA or ARCP certified, or obtained within 2 years of hire
• Bachelor's degree with at least 5 years of experience, or an equivalent combination of education and work experience in a research setting
• Implementation of GCP, ICH guidelines, and applicable regulatory guidelines in the conduct of clinical research
• Experience in reading medical records
• Proficient in electronic data capture systems, e.g., OpenClinica, REDCap Cloud
• Ability to communicate effectively and follow written and verbal instructions
• Demonstrate strong analytical and organizational skills, including high level accuracy and attention to detail while exercising good judgment
• Proven ability to set priorities, exercise initiative, work simultaneously on numerous projects and meet/negotiate deadlines
• Ability to effectively work independently, as well as with diverse teams
• Demonstrate efficient organizational skills and ability to effectively problem solve and implement solutions to improve processes
• Excellent interpersonal and conflict resolution skills