The University of Michigan’s Division of Metabolism, Endocrinology and Diabetes, and its Weight Management Program is looking for a clinical project manager. This position has the oversight for clinical project (s) and responsibility for ensuring project completion within specifications. The CRPM assists with project development, establishes operational objectives and assignments; defines and manages project resource needs, timelines and budgets; reporting; and analyzes, compares and evaluates courses of action.
Identifies resources and budgets needed to support the project. Facilitates and coordinates communication, schedules, timelines and activities among the various stakeholders. Will assist with database development, and be responsible for database entry/management.
Project Initiation, Oversight, & Reporting:
- Manage the day-to-day operations of the various components related to the study conduct
- Reviews the project guidelines and requirements
- Assists with designing source documents, recruitment materials, and other relevant study documents for projects
- Ensures that regulatory requirements are in place prior to project initiation (IRB approvals, HIPAA, FDA, ICH, standard operating procedures, billing calendars, study budgets, patient consents, execution of study protocol, clinicaltrials.gov study registration, advertising and promotion of project, study close-out and record retention, etc.
- Attends investigator meetings as part of the study team for project initiation
- Oversees the recruitment and assignment of trained study team members
- Ensures that key personnel meet training requirements in accordance to sponsor, federal and other regulatory guidelines
- Oversees audits, case report, study visits, data safety monitoring compliance and federal reporting where required
- Oversees the management of space and equipment
- Participates in recruitment strategic planning meetings
- Manages reporting of patient adverse events and medical condition changes
- Provide statistical support for project results and reporting
- Manage data in eResearch Regulatory Management
- Oversees subject incentives and required documentation
- Reviews study budgets, enrollment updates, and timelines in a consistent and continuous manner
- Assists with dispute resolutions
- Manages biological sample collection
- Liaison to OHRCR, IRB staff, other School of Medicine and Public Health department personnel regarding clinical research activities
- Supervision and training of staff
- Provides guidance, training, and mentorship to study personnel
- Oversees the development and implementation of administrative procedures and assignments
- Recommends strategic direction and provides leadership in short and long-range objectives
Bachelor’s degree (preferred Master’s level) in a health science or related field with at least 2-3 years working in clinical research. Experience in a direct patient care setting or outpatient clinic preferred. Candidates with previous experience with clinical research project budgets, experience with ClinicalTrials.govalong with experience working with the Human Subjects Incentives Program (HSIP) are given priority. Demonstrated understanding of Good Clinical Practice (GCP), International Council on Harmonisation (ICH) and Food and Drug Administration (FDA) regulations. Must have computer proficiency in Microsoft Word, Excel, and Power Point. Confident and highly motivated with excellent multi-tasking ability and record keeping skills. Professional demeanor and excellent interpersonal, communication and writing skills. Proven ability to work independently with minimal supervision. Ability to work with diverse teams of people in a diplomatic and collaborative environment. Ability to problem solve and establish timelines and priorities. Excellent organizational skills with meticulous attention to details. Excellent attendance record.
Advanced Degree. Previous experience in Clinical Research Design and Statistical Analysis, the Michigan Budget Enrollment Calendar Tool (MBECT) and MiChart. Supervisory experience desired as well as experience in database development and management (including surveys using Redcap, Velos, etc). ACRP or SOCRA certified or willingness to become certified. PEERS certified. Working knowledge of medical terminology and the ability to sustain a high level of organization while supporting numerous aspects and components of a large, multidisciplinary project.
This position is located in the Division of Metabolism, Endocrinology & Diabetes, 24 Frank Lloyd Wright Dr, Lobby G.
University of Michigan Health System 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.
Job openings are posted for a minimum of seven calendar days. This job may be removed from posting boards and filled anytime after the minimum posting period has ended.
U-M EEO/AA Statement
The University of Michigan is an equal opportunity/affirmative action employer.