Multisite Operations Manager

The Chronicle Of Higher Education, Inc.; Salt Lake City (UT); Hybrid; USD 40,000 - 85,000; Full time

Job summary

The Chronicle Of Higher Education, Inc. in Salt Lake City is seeking an Operations Project Manager, II to oversee multi-site trials and regulatory submissions from start-up to closeout.

The role requires managing clinical trial regulatory documents, liaising between clinical sites, the Research Compliance Office, and sponsors, and ensuring compliance with GCP/ICH guidelines. Hybrid remote/in-office schedule offered.

Qualifications

• Equivalency statement allows substitution of education for work experience.
• Bachelor's degree or equivalent required for the role.
• Developing-Level position in General Professional track.

Responsibilities

• 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.
• Ensure targets and requirements are met and completed on schedule and within budget.
• Maintain regulatory documents and study progress in trial master files.
• Act as liaison between clinical site(s), PI, regulatory team and sponsors.

Skills

Project management

Regulatory knowledge

Leadership

Communication skills

Attention to detail

Independent work

Education

Bachelor's degree or equivalent

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

MS Project

Job description

Multisite Operations Manager

Job Summary

This position will provide project and regulatory managementoversight for multi-site trials coordinated by the ResearchCompliance Office from trial start-up through trial closeout. Theincumbent will act as a liaison between the external participatingclinical sites, the Research Compliance Office andsponsors/agencies to ensure that clinical trials are conducted incompliance with the protocol, and applicable institutional andregulatory guidelines. Independently utilizes experience and expertise to accurately andefficiently manage the submission of regulatory documents to ensurecompliance with governing requirements for human subject research.Manages complex and non-routine regulatory functions. Responsiblefor making independent decisions regarding protocol issues andresolving protocol deviations. Ensures compliance by providingregulatory oversight of investigator initiated clinicaltrials. As a member in the Research Compliance Office department, thecandidate may also be responsible for quality assurance oversightof clinical trials and reporting study progress to the Data SafetyMonitoring Committee (DSMC). This job has the ability to be ahybrid schedule of remote and in office work.

Responsibilities

Operations Project Manager, II

Plan and execute internal operations/non-technical projects from initiation throughdelivery. Gather required data from end users to evaluateobjectives, goals, and scope to define deliverables. Focus onexecution and managing the functional elements of the project.Ensure that all targets and requirements are met and are completedon schedule and within budget. Work closely with various internaldepartments to ensure successful completion of projects. Keepleadership informed of key issues that may impact projectcompletion, budget, or other results. Requires moderate skill setand proficiency in discipline. Conducts work assignments ofincreasing complexity, under moderate supervision with somelatitude for independent judgment.Requires a bachelor's (orequivalency) + 4 years or a master's (or equivalency) + 2 years ofdirectly related work experience.This is a Developing-Levelposition in the General Professional track.

Essential Functions

• Develop and maintain sitefeasibility packets, multi-site study procedural manuals, and othermulti-site process documents.
• Prepare clinical sites for studystart-up by reviewing and tracking regulatory documents, orderingstart-up supplies and conducting site initiation visits.
• Ensuresupdated copies of regulatory essential documents are maintained intrial master files and manages the study progress in relation tothe project timelines.
• Assure that the clinical sites areenrolling subjects, collecting data, and conducting the trial incompliance with approved protocol version, GCP and ICHguidelines.
• Communicate with external sites determinations madeon behalf of the DSMC.
• Oversees the maintenance and organizationof project documentation and records.
• Act as a liaison betweenthe clinical site(s), HCI University parties (PI, regulatory team,study team, etc.) study sponsors and/or regulatory agencies and theresearch compliance office to resolve any issues that may arisethroughout the course of the study.
• Other responsibilities mayinclude but are not limited to; updating and revision of SOPs,training and orientation of study staff, organization ofcoordinator/investigator meetings.
• Provides guidance and trainingto research faculty and staff pertaining to complex and highlyspecialized rules and regulations including complex protocol,multi-site trials and IND/IDE regulations.
• Assist in thedevelopment and submission of investigator initiated clinicalstudies to appropriate regulatory review committees.
• Ensures participating sites provide the necessary regulatory documentationto participate in a multi-site investigator initiated trial.
• Assists in the development of policies, procedures and processimprovements for departmental implementation and guidance forexternal associates.
• Perform other duties as assigned bymanagement.

Problem Solving

This position utilizes federal,institutional guidelines and requirements to inform and completesubmission of regulatory documents. This position also negotiateswith University research committees and sponsors to ensure fullcompliance and communication. The incumbent decides how to best accomplish the daily requirementsof various regulatory objectives, prioritizes workload andestablishes systems needed to achieve specific goals. Efforts ofmultiple departments or disciplines must be coordinated to ensureeffective follow through and compliance of all involved followingFDA, Good Clinical Practice, IRB, NIH, and/or other regulatoryagency guidelines. Incumbent will be responsible for resolvingand/or making appropriate recommendations for correction or fullresolution to the Director and other members of the managementteam.

Minimum Qualifications

EQUIVALENCY STATEMENT: 1 year of higher educationcan be substituted for 1 year of directly related work experience(Example: bachelor's degree = 4 years of directly related workexperience).

Department may hire employee at one of the following joblevels

Operations Project Manager, II: Requires a bachelor's (or equivalency) + 4 years or a master's (orequivalency) + 2 years of directly related work experience.

Preferences

• Experience in the management of clinical trials and theinvestigator initiated clinical development process.
• Oncologyclinical trial experience highly preferred.
• Working knowledge ofFood and Drug Administration (FDA) requirements, Office of HumanResearch Protection (OHRP), International Conference ofHumanization (ICH) Good Clinical Practice (GCP), as well as stateand federal guidelines.
• Knowledge of clinical development processsufficient to effectively direct and manage multiple projects andtimelines.
• Strong attention to detail, establishing priorities,and adhering to deadlines.
• Able to show initiative and workindependently, take initiative and complete tasks to meetdeadlines.
• Excellent interpersonal communication (including oraland written) and leadership skills also required.
• Proficient instandard Microsoft office applications including Word, PowerPoint,Excel, Project, and other project management tools.
• SOCRA or ACRPcertification.

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:

To apply, visit https://apptrkr.com/9752003 https://utah.peopleadmin.com/postings/206757