Operations Manager, Clinical Research

PSI CRO

$90K — $110K *
US-AnywhereRemote in United States
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Associate degree in life sciences or similar, with a preference for Business Management certification.
  • ICH GCP Training certification required.
  • Minimum 5 years of leadership experience in a clinical research facility, preferably with network experience.
  • Direct experience across the full life cycle of clinical research activities from pre-award through close-out.
  • Fluent in English with excellent communication skills.
  • Proficient in MS Office applications.
  • Valid category B driver's license required.

Responsibilities

  • Assess feasibility of research protocols and recommend suitable trials for institutions.
  • Monitor budget negotiations and study activation timelines for site readiness.
  • Manage a team of Lead Study Coordinators, ensuring quality and performance of their work.
  • Drive process improvement and standardize clinical trial operations according to regulatory requirements.
  • Create a work culture that promotes transparency, accountability, and continuous learning.

Benefits

  • Opportunity to join a developing company where employee contributions are valued.
  • Encouragement of independence and accountability among staff.
  • Commitment to staff development and continuous learning.
Full 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 Additional Information If you want to join a developing company where people matter, you're independent and accountable, Milestone One is the right place for you.

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