Clinical Operation Manager
Core
Manage day-to-day monitoring activities on assigned clinical studies, ensuring deliverables are met by tracking project metrics and status.
Role type
Senior Clinical Operation Manager (Monitoring)
Builds
Clinical trial monitoring deliverables and study portals
Domain
Pharmaceutical clinical trials
Required skills
Clinical monitoring, Site feasibility review, Risk Based Monitoring (RBM), Protocol deviation management, Training RSMs, eCRF review, ICH/GCP compliance
Preferred skills
Lead monitor experience, Complex therapeutic area knowledge
Technologies
Microsoft Word, Microsoft PowerPoint, Microsoft Excel, Microsoft OneNote, Study portals
Responsibilities
Manage day-to-day monitoring activities on assigned study, Act as a resource for RSMs to answer study questions, Review completed Site Feasibility Questionnaires and Site Qualification Visit reports, Develop monitoring documents and toolkits for trial, Conduct teleconferences with RSMs to deliver training, Collaborate with CTT and GSMO PL in review of study specific eCRFs, Serve as Risk Based Monitoring (RBM) ambassador, Maintain monitoring portion of study portal, Conduct site presence visits, Mentor new LSMs
Seniority
Senior, hands-on IC