Operations Manager, Clinical Research

Job Description
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.

Qualifications
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