SABER Project Manager

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 your experience that directly relates to this position.

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The Statistical Analysis of Biomedical and Educational Research (SABER) unit is the data coordinating center for several multi-center clinical trials and observational studies. We are a research center located within the Biostatistics Department at the School of Public Health (SPH) on Michigan's central campus. SABER clinical study monitors provide independent oversight of study conduct and collaborate with project managers, principal investigators, and coordinating center leadership to ensure compliance and alignment across study activities.

We work with clinical sites to move the project forward according to Good Clinical Practice (GCP) guidelines. We are looking for an experienced and dynamic staff member to contribute positively to our community.

SABER prides itself on fostering a collegial, open, and family-friendly work environment, and our team is fully remote.

Project Coordination and Stakeholder Communication

• 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.

Study Operations and Site Management

• 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.

Data Quality, Monitoring, and Data Management Support

• 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.

Regulatory, Safety, and Compliance Support

• 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.

• 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., Open Clinica, 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,…