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 Project Intermediate Manager position will be in support of the Oncology Clinical Trials Support Unit (O-CTSU) Monitoring/Project Management Team/Program. The position requires the ability to represent the team and/or project leadership among many different stakeholders in a highly professional manner; the ability to multi-task and meet deadlines while maintaining attention to detail. The Project Intermediate Manager must possess the ability to independently and collaboratively identify and communicate opportunities, metrics, and challenges to Team and/or Project(s) and act on them in a timely fashion. The successful candidate will demonstrate excellent organizational and communication skills and a desire to work in partnership with the Program’s faculty leaders. The incumbent will act as a liaison between the clinical sites, the O-CTSU and sponsors/agencies/cooperative groups to ensure that clinical trials are conducted in compliance with the protocol, and applicable institutional and regulatory guidelines. Project Intermediate Manager activities include: providing project management support/oversight, regulatory and data management oversight and clinical monitoring support for multi-site trials coordinated by the O-CTSU from trial start-up (inclusive of contracting) through trial closeout.
Develop and maintain study manual of operations, and standard data collection procedures, Clinical Monitoring Plan and other study documents. Maintain master trial files and manages the study progress in relation to the project timelines. Assure that the clinical sites are enrolling subjects, collecting data, and conducting the trial in compliance with approved protocol version, GCP and ICH guidelines and verify patient eligibility. 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. Monitor adverse events for seriousness and facilitate the AE/SAE reporting process to ensure that all adverse events are reported to the study supporter and all participating site IRBs. Act as a liaison between the clinical site(s) and the data coordinating center to resolve any issues that may arise throughout the course of the study.
Other responsibilities may include but are not limited to:
Overseeing the maintenance and organization of the team, and/or project documentation and records. Act as a liaison between the team, O-CTSU leadership, and/or project leadership.
The successful candidate will have the opportunity to contribute towards program direction and initiatives.
Serves as a resource and contact person for protocols
Liaison between Supporters and project/team leadership to develop processes, troubleshoot complications and facilitate communication
Integrates the workflow of many studies running simultaneously
Maintains current PEERRS, or OHRP certification; knowledge and application of the Code of Federal Regulations (CFR), Good Clinical Practice (GCP), and FDA regulations. and maintains knowledge of current ICH and CFR guidelines
Work well in a team setting, but also independently when appropriate and regularly exercise good judgment in setting priorities, resolving operational problems, and applying policies, procedures, and methods, while maintaining the strictest of confidentiality at all times
Update and revision of SPGs
Training and orientation of team and/or study staff
Participate in group and department initiatives
Maintain a strong positive relationship with O-CTSU Leadership, team, and stake holders
Organize and prepare background material for team and/or project meetings, as applicable
Follow up on decisions and other assignments that result from meetings
Monitor progress of assignments to ensure timely completion
Coordinate/Perform recruiting and hiring activities for O-CTSU Monitoring/Project Management Team
Develop Internal and External Communications, as applicable
Represent team/program in professional correspondence and interactions
Perform other duties as assigned by management/Leadership
Bachelor’s degree or higher in health science or health-related field
10+ years and/or experience in clinical research site management, regulatory management and data management
SOCRA or ACRP certification
Excellent written and verbal communication skills
Strong organizational skills with ability to multitask and prioritize
Must have exceptional attention to detail and understanding of compliance issues with regard to human subject research
Success in effectively meeting deadlines with quality deliverables
Outstanding teamwork and customer service orientation
Ideal candidate will have strong knowledge of 45 CFR part 46 and 21 CFR parts 50
Willingness to travel up to 30% for monitoring trips
A Master’s degree in biomedicine, life sciences or Clinical Research Administration
Knowledge of the University’s procedures and policies
Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings. Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.
Job openings are posted for a minimum of seven calendar days. The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled anytime after the minimum posting period has ended.
The University of Michigan is an equal opportunity/affirmative action employer.
Internal Number: 193128
About University of Michigan - Ann Arbor
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