Clinical Research Manager

University of Wisconsin Madison•Madison, WI

22h•Hybrid

About The Position

The Department of Obstetrics and Gynecology at the University of Wisconsin School of Medicine and Public Health is seeking a Clinical Research Manager to plan, develop, and direct clinical research operations within the department. This position provides strategic and operational oversight for one or multiple clinical research programs and serves a key role in advancing the department’s mission in reproductive health research, education, clinical care, and advocacy. The Clinical Research Manager will oversee clinical trial operations, ensure regulatory compliance, supervise research staff, manage budgets and research portfolios, and support the development and submission of grant proposals and protocols. This role works collaboratively with investigators, sponsors, regulatory bodies, and institutional partners to ensure high-quality and compliant research operations that support the department’s continued excellence in translational and clinical research. Founded in 1929, the Department of Obstetrics and Gynecology has a long-standing tradition of leadership in reproductive health. Today, our physicians, advanced practice providers, researchers, trainees, and staff remain united in a shared commitment to improving reproductive health outcomes through innovation, collaboration, and academic excellence. This position may require some work to be performed in-person, onsite, at a designated campus work location. Some work may be performed remotely, at an offsite, non-campus work location. This position has been identified as a position of trust with access to vulnerable populations. The selected candidate will be required to pass an initial caregiver check to be eligible for employment under the Wisconsin Caregiver Law and every four years.

Requirements

5 years employment experience in Clinical Research or Clinical Trial management is required by the start date of the position.
Master's degree preferred; focus on Life Science/Healthcare preferred
HIPAA, FERPA, GCP, ICH/FDA compliance, IRB processes, clinical trial lifecycle
Plan/manage timelines, budgets, risks, and multiple concurrent studies
Lead cross-functional teams; resolve deviations/issues; engage sponsors, sites, and stakeholders effectively
EDC, Florence, OnCore, Team Work, REDCap, Arrow, RAMP, Qualtrics, Excel, and Advarra Participant Payments
Strong organization, ensure quality, attention to detail, adaptability, ethical judgment, and decision-making
Must provide proof of work authorization and eligibility to work.

Responsibilities

Plans staff implementation of protocols and on-going quality review of one or multiple, basic or moderately complex clinical research trials or programs
Analyzes research portfolios and accounts, solicits internal and external research opportunities, promotes unit capabilities, and makes recommendations to leadership for strategic program enhancements
Compiles audits and documents research data to ensure necessary compliance with institutional policies and procedures
Composes, assembles, and submits grant proposals and protocols according to applicable rules and regulations
Exercises supervisory authority, including hiring, transferring, suspending, promoting, managing conduct and performance, discharging, assigning, rewarding, disciplining, and/or approving hours worked of at least 2.0 full-time equivalent (FTE) employees
Develops and monitors the program budget; and reviews and approves expenditures