Live opening · Posted 7 days ago
Operations Manager, Clinical Research
PSI CRO · remote, REMOTE, United States
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At a glance
The key details from the original listing.
CompanyPSI CRO
Locationremote, REMOTE, United States
Job typeFull-time
Work modeYes
Source
Smartrecruiters
Listed7 days ago
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About the role
Description supplied by the original job listing.
The Manager Operations is responsible for overseeing the operational conduct of clinical trials at
contracted medical institutions within a defined country or region in accordance with Milestone One
contractual obligations. The Manager Operations provides leadership to Lead Site Coordinators and
Site Coordinators, serving as a subject matter expert and escalation point for operational issues. This
position plays a key role in staff development, process improvement, and continuous operational
excellence.
SCOPE OF RESPONSIBILITIES
Assesses feasibility of research protocols by reviewing clinical, operational, and resource requirements and recommending suitable trials for the medical institution.
Monitors the progress of budget negotiations and study activation timelines to support timely site readiness.
Manages the team of (Lead) Study Coordinators, oversees the quality and results of their work by monitoring and follow-up of study related reports, timesheets, site trackers and other operational tools to ensure satisfactory performance of the Milestone One team.
Drives process improvement and standardization of clinical trial operations in alignment with ICH GCP, regulatory requirements, MO1 Controlled Documents, by contributing to the development of operational guidelines, templates, and procedures.
Creates a work culture environment that promotes process transparency, accountability, and continuous learning.
Associate degree in life sciences or similiar. Business Management degree or certification is a plus.
Certifications ICH GCP Training
Minimum 5 years of clinical on the job experience, in a leadership position at a clinical research facility or Network experience is highly preferred.
Knowledgeable and direct experience in the full life cycle of clinical research activities from pre-award through close out.
Fluent use of English
Proficiency in MS Office
Valid category B driver’s license
Excellent communications skills
Excellent management skills, experience managing remote staff preferred.
Effective problem solving and result oriented
Accountable
Team leadership skills
Employment type
Full-time
Work arrangement
Yes
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