Director Clinical Monitoring and Site Management (m/w/d)
Core
Leading the Clinical Monitoring and Site Management department to ensure quality, efficiency, and KPI-driven control for successful clinical trials.
Role type
Director, Clinical Operations (Monitoring & Site Management)
Builds
Clinical trial monitoring processes and site management structures
Domain
Clinical Research / Pharmaceutical Industry
Required skills
Risk-Based Monitoring (RBM) strategy implementation, Line and Second Line Management, SOP development, KPI management, Change management, Regulatory knowledge (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 Risk-Based Monitoring strategies; Create and update SOPs and Work Instructions; Manage a KPI-based management system; Derive and implement CAPAs; Ensure effective use of modern systems; Lead cross-functional projects; Plan and communicate change processes
Seniority
Director, strategic leadership & team management