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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.

Job Summary

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 seeking a highly motivated and experienced individual who will report to the SABER Director who will provide supervision and leadership of our growing group of project managers and clinical monitors.  This individual will also be responsible for leading and overseeing effective day-to-day operational aspects of multiple clinical research studies as an individual contributor. These responsibilities include study management, project management, and monitoring of the clinical sites with respect to both regulatory compliance and data quality. The position requires travel within the United States to participating clinical sites and to Investigator Meetings. 

Responsibilities*

Supervision Responsibilities of Project Management and Clinical Monitoring Group:

  • Supervise SABER project managers and clinical monitors, including professional development, continuing education, and performance appraisal
  • Manage the resources and activities of the group, in collaboration with SABER’s Managing Director, including to ensure studies are managed and monitored in a timely, thoughtful and efficient manner

 

Leadership Responsibilities of Project Management and Clinical Monitoring:

  • Revise, implement standard operating procedures, develop training programs, coordinate common work practices among project/clinical managers to ensure the SABER group is adhering to best practices and all relevant
  • Identify, propose and apply appropriate  clinical trials operational methodologies and processes regarding project management and clinical monitoring, which may necessitate literature reviews, independent research or collaboration with faculty and SABER staff
  • Contribute in writing proposals, reports for funding agencies and articles for publication;
  • Present results of innovative project management or clinical monitoring initiatives at professional meetings and other forums
  • Participate as an active and engaged member of the SABER Leadership Team

 

Project Management and Clinical Monitoring Responsibilities:

  • Work independently on projects, providing periodic updates to supervisor
  • Provide oversight, project management, project coordination and clinical monitoring for multi-center clinical trials and observational studies
  • Be responsible for all data coordinating center IRBMED submissions, including new protocols, amendments, aggregate safety reporting, and scheduled annual reviews;
  • Be the interface between the data coordinating center and the clinical sites, maintaining positive and cooperative relationships in day-to-day interactions with investigators and study sites
  • Participate in the design, development and execution of clinical trials and observational studies, including:
    • Create and update study manual of operations and standard data collection procedures for all participating clinical sites
    • Maintain master trial files, and manage the study progress in relation to project timelines
    • Monitor clinical sites for compliance with GCP and ICH guidelines, including completion of regulatory documents and proper completion of case report forms
    • Assist with design of case report forms, database validation and error variables for data entry
    • Prepare clinical sites for study start-up by reviewing and tracking regulatory documents, ordering start-up supplies, and conducting site initiation visits
    • Conduct ongoing site monitoring visits, and prepare detailed monitoring visit reports
    • Screen all adverse events for seriousness and facilitate the AE/SAE reporting process to ensure that all adverse events are reported to the study sponsor and all participating site IRBs
    • Prepare and submit IND and annual reports to FDA

Required Qualifications*

  • Master’s degree in an appropriate field or an equivalent combination of education and experience are necessary
  • At least 6 years’ experience in clinical trials research, preferably as a project/clinical manager
  • Experience in reading medical records
  • Training/experience as a clinical monitor
  • At least 3 years of significant administrative/supervisory experience, preferably in academic or research units
  • Demonstrated ability to lead teams, integrate activities, and manage change
  • Exceptional attention to detail
  • Able to multi-task and manage competing priorities effectively
  • Ability to make independent decisions on matters of significance, free from immediate direction, within the scope of responsibilities
  • Excellent organization, verbal, written and interpersonal skills are required
  • Understanding of ICH, GCP and FDA regulations and guidelines with regard to the conduct of human subject research
  • Willingness to travel 10% - 25% of the time
  • Certification as a clinical research associate or the equivalent is desirable

Additional Information

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. 

 

Background Screening

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.