Multisite Operations Manager

University of Utah

Salt Lake City (UT)

Hybrid

USD 40,000 - 85,000

Full time

8 days ago

Get more replies from employers

Send a job-specific resume in minutes.

Job summary

University of Utah, Huntsman Cancer Institute, seeks an Operations Project Manager, II to oversee multi-site clinical trials from start-up to closeout. You will liaise with external sites, the Research Compliance Office, and sponsors to ensure protocol adherence and regulatory compliance.

The role requires coordinating regulatory submissions, managing complex documents, and ensuring trial progress aligns with timelines while maintaining data quality and patient safety.

Qualifications

Requires a bachelor’s degree or higher and related work experience.
4 years of directly related work experience with a bachelor’s degree or 2 years with a master’s degree.
Experience in managing clinical trials, especially investigator-initiated or oncology trials, is preferred.
Working knowledge of FDA, OHRP, ICH GCP guidelines and related federal/state regulations.

Responsibilities

Plan and execute internal operations/non-technical projects from initiation through delivery.
Gather data from end users to evaluate objectives, goals, and scope to define deliverables.
Ensure targets are met, on schedule and within budget; collaborate with internal departments.
Maintain regulatory documents in trial master files and track study progress against timelines.
Oversee site readiness, regulatory submissions, and contract/feasibility processes.
Provide guidance on SOP updates, staff training, and investigator meetings.

Skills

Clinical trial management

Regulatory compliance

Project coordination

Communication skills

Microsoft Office

Education

Bachelor's degree or higher

Tools

Microsoft Word

Microsoft PowerPoint

Microsoft Excel

Microsoft Project

Job description

Job Summary

This position will provide project and regulatory management oversight for multi-site trials coordinated by the Research Compliance Office from trial start-up through trial closeout. The incumbent will act as a liaison between the external participating clinical sites, the Research Compliance Office and sponsors/agencies to ensure that clinical trials are conducted in compliance with the protocol, and applicable institutional and regulatory guidelines.

Job Summary

Independently utilizes experience and expertise to accurately and efficiently manage the submission of regulatory documents to ensure compliance with governing requirements for human subject research. Manages complex and non-routine regulatory functions. Responsible for making independent decisions regarding protocol issues and resolving protocol deviations. Ensures compliance by providing regulatory oversight of investigator initiated clinical trials.

As a member in the Research Compliance Office department, the candidate may also be responsible for quality assurance oversight of clinical trials and reporting study progress to the Data Safety Monitoring Committee (DSMC). This job has the ability to be a hybrid schedule of remote and in office work.

Huntsman Cancer Institute is committed to cancer prevention, care, and survivorship for all communities within the area we serve – which includes Idaho, Montana, Nevada, Utah, and Wyoming – with impact worldwide.

In your cover letter or during your interview process, we invite you to share how your professional experiences have prepared you to serve as a member of our team as we work to reduce the cancer burden experienced by all people and communities. This may include description of your prior experiences related to research, prevention, clinical care, community engagement/outreach, training, administration, or other areas relevant to Huntsman Cancer Institute's mission and this position.

Responsibilities

Operations Project Manager, II

Plan and execute internal operations/non-technical projects from initiation through delivery. Gather required data from end users to evaluate objectives, goals, and scope to define deliverables. Focus on execution and managing the functional elements of the project. Ensure that all targets and requirements are met and are completed on schedule and within budget. Work closely with various internal departments to ensure successful completion of projects. Keep leadership informed of key issues that may impact project completion, budget, or other results. Requires moderate skill set and proficiency in discipline. Conducts work assignments of increasing complexity, under moderate supervision with some latitude for independent judgment.Requires a bachelor's (or equivalency) + 4 years or a master's (or equivalency) + 2 years of directly related work experience.This is a Developing-Level position in the General Professional track.

Essential Functions:

Develop and maintain site feasibility packets, multi-site study procedural manuals, and other multi-site process documents.
Prepare clinical sites for study start-up by reviewing and tracking regulatory documents, ordering start-up supplies and conducting site initiation visits.
Ensures updated copies of regulatory essential documents are maintained in trial master 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.
Communicate with external sites determinations made on behalf of the DSMC.
Oversees the maintenance and organization of project documentation and records.
Act as a liaison between the clinical site(s), HCI University parties (PI, regulatory team, study team, etc.) study sponsors and/or regulatory agencies and the research compliance office to resolve any issues that may arise throughout the course of the study.
Other responsibilities may include but are not limited to; updating and revision of SOPs, training and orientation of study staff, organization of coordinator/investigator meetings.
Provides guidance and training to research faculty and staff pertaining to complex and highly specialized rules and regulations including complex protocol, multi-site trials and IND/IDE regulations.
Assist in the development and submission of investigator initiated clinical studies to appropriate regulatory review committees.
Ensures participating sites provide the necessary regulatory documentation to participate in a multi-site investigator initiated trial.
Assists in the development of policies, procedures and process improvements for departmental implementation and guidance for external associates.
Perform other duties as assigned by management.

Problem Solving

This position utilizes federal, institutional guidelines and requirements to inform and complete submission of regulatory documents. This position also negotiates with University research committees and sponsors to ensure full compliance and communication.

The incumbent decides how to best accomplish the daily requirements of various regulatory objectives, prioritizes workload and establishes systems needed to achieve specific goals. Efforts of multiple departments or disciplines must be coordinated to ensure effective follow through and compliance of all involved following FDA, Good Clinical Practice, IRB, NIH, and/or other regulatory agency guidelines. Incumbent will be responsible for resolving and/or making appropriate recommendations for correction or full resolution to the Director and other members of the management team.

Minimum Qualifications

EQUIVALENCY STATEMENT:

1 year of higher education can be substituted for 1 year of directly related work experience (Example: bachelor's degree = 4 years of directly related work experience).

Department may hire employee at one of the following job levels:

Operations Project Manager, II:

Requires a bachelor's (or equivalency) + 4 years or a master's (or equivalency) + 2 years of directly related work experience.

Preferences

Experience in the management of clinical trials and the investigator initiated clinical development process.
Oncology clinical trial experience highly preferred.
Working knowledge of Food and Drug Administration (FDA) requirements, Office of Human Research Protection (OHRP), International Conference of Humanization (ICH) Good Clinical Practice (GCP), as well as state and federal guidelines.
Knowledge of clinical development process sufficient to effectively direct and manage multiple projects and timelines.
Strong attention to detail, establishing priorities, and adhering to deadlines.
Able to show initiative and work independently, take initiative and complete tasks to meet deadlines.
Excellent interpersonal communication (including oral and written) and leadership skills also required.
Proficient in standard Microsoft office applications including Word, PowerPoint, Excel, Project, and other project management tools.
SOCRA or ACRP certification.

Special Instructions

Requisition Number: PRN45848B

Full Time or Part Time? Full Time

Work Schedule Summary

Department: 01345 - HCI Clinical Resrch Compliance

Location: Campus

Pay Rate Range: $39,815 to $85,000

Close Date: 11/01/2026

Open Until Filled

Get your free, confidential resume review.

or drag and drop your file here.