Director Clinical Monitoring and Site Management (m/w/d)
Core
Lead the Clinical Monitoring and Site Management department, focusing on quality, efficiency, and strategic implementation of Risk-Based Monitoring (RBM) to ensure successful clinical studies.
Role type
Director, Clinical Operations (Monitoring & Site Management)
Builds
Clinical study monitoring processes and site management structures for pharmaceutical/medical research clients (via careerplan.io/jobs/2655988-director-clinical-monitoring-and-site-management-mwd-at-gbg-forschungs-gmbh)
Domain
Clinical Research / Pharmaceutical Industry
Required skills
Risk-Based Monitoring (RBM) strategy implementation, Line and Second Line Management, SOP development, KPI-based management, Change management, Regulatory compliance (ICH-GCP, EU-CTR), Team leadership, System utilization (CTMS, eTMF, LMS)
Preferred skills
Entrepreneurial mindset, Data-driven decision making, Digitalization affinity
Responsibilities
Lead and develop the Monitoring and Site Management department including resource planning; Ensure compliance with SOPs, regulations, and timelines; Collaborate with international partners and stakeholders; Implement and optimize RBM strategies; Create and update SOPs and Work Instructions; Manage a KPI-based system for monitoring quality and timelines; Derive and implement CAPAs; Ensure effective use of modern systems (CTMS, eTMF, LMS); Plan and communicate change processes
Seniority
Director, strategic leadership & team management