Clinical Operations Manager
Core
Manage day-to-day monitoring activities on assigned clinical studies to ensure deliverables are met by tracking project metrics and status of deliverables.
Role type
Senior Clinical Operations Manager (Monitoring)
Builds
Clinical trial monitoring deliverables and study process toolkits
Domain
Pharmaceutical clinical trials
Required skills
Clinical trial monitoring, Site feasibility review, Risk Based Monitoring (RBM) implementation, Protocol deviation management, eCRF review, ICH/GCP compliance, Training RSMs, Mentoring LSMs
Preferred skills
Lead monitor experience, Complex therapeutic area experience
Technologies
Microsoft Word, Microsoft PowerPoint, Microsoft Excel, Microsoft OneNote, Study portal
Responsibilities
Manage day-to-day monitoring activities on assigned study to ensure deliverables are met by tracking and maintaining project metrics and status of deliverables, Act as a resource for RSMs to answer study questions and provide guidance as Allergan standard study process experts, Review completed Site Feasibility Questionnaires, Site Qualification Visit reports and maintains all tracking reports (SIV, IMV, RMV, COV) for assigned trial, Develop monitoring documents and toolkits for trial to ensure consistency such as Protocol Specific Monitoring Plan and amendments, report annotation, visit checklists, tool kits, etc., Conduct with RSM teleconferences to deliver training and information as required, Collaborate with CTT and GSMO PL in review of study specific eCRFs, completion guidelines, protocol deviation specifications, user acceptance testing, etc., Serve as Risk Based Monitoring (RBM) ambassador ensuring implementation and adherence to RBM requirements on trial, Maintain monitoring portion of study portal, Site presence (may be responsible for monitoring 1 sites on assigned trial or co-monitoring/oversight visits, etc.), Principal LSM additional tasks: mentoring new LSMs, assisting with LSM orientation training sessions, contribute to process development, improvement and documents to drive consistency