Operations Manager, Clinical Research

PSI CRO

$95K — $115K *
US-AnywhereRemote in United States
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Associate degree in life sciences or similar required; Business Management degree or certification is a plus.
  • Certifications in ICH GCP Training needed.
  • Minimum of 5 years of clinical experience in a leadership role at a clinical research facility, with network experience preferred.
  • Direct experience in the full life cycle of clinical research activities from pre-award through close-out is essential.
  • Fluent English proficiency required; strong communication skills are crucial.
  • Proficiency in MS Office and a valid category B driver's license are needed.

Responsibilities

  • Assess feasibility of research protocols and recommend suitable trials for medical institutions.
  • Monitor budget negotiations and study activation timelines for timely site readiness.
  • Manage a team of (Lead) Study Coordinators and ensure performance quality through oversight of related reports and tools.
  • Drive process improvements and standardization of clinical trial operations, aligning with regulatory requirements.
  • Create a work culture that promotes process transparency, accountability, and continuous learning.

Benefits

  • Opportunity to work in a developing company that values its people.
  • Independence and accountability are encouraged in the workplace.
  • Focus on staff development and operational excellence.
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.

Similar Jobs

More Jobs at PSI CRO

More Pharmaceuticals & Biotech Jobs

Find similar Operations Manager, Clinical Research jobs: