Apply on Employer Site

One Life Science · 2 days ago

Director of clinical operations

United States

Full-time

Remote

Director/Executive

8+ years exp

One Life Science is seeking a Global Sr. Manager/Associate Director of Clinical Operations for an innovative ophthalmology device company. This role involves overseeing global clinical trial operations, managing a clinical operations team, and ensuring compliance with clinical study regulations.

Staffing & Recruiting

Hiring Manager

Dan Byrne

Responsibilities

Provide strategic and operational input into global clinical study planning and execution, ensuring the pipeline is resourced and aligned with company objectives

Oversee day-to-day global trial operations, including CRO/monitor oversight, site engagement, and vendor management

Lead and develop the clinical operations team, including hiring, training, and performance management

Drive preparation, submission, and tracking of clinical documents (protocols, IBs, CRFs, ICFs, study reports) and support IRB/EC interactions and compliance

Monitor quality, timelines, budgets, and risk, including identification/escalation of issues, implementing preventative/mitigation measures, and reporting trial progress to senior stakeholders

Collaborate with data management and cross-functional teams on database specifications, data review, and query management; support field case coverage and site monitoring as needed

Qualification

Clinical trial operationsHuman-subject research regulationsGCPICH knowledgeLeadership skillsOrganizational skillsCommunication skillsProject management