FSP Manager/Senior Manager Clinical Operations - Germany (m/f/d)
Core
Oversee, train, resource, coach, and performance manage a team of clinical operations staff, ensuring adherence to SOPs and WPDs while driving end results via metrics and KPIs.
Role type
Senior Individual Contributor (Manager)
Builds
Clinical operations teams and project delivery for pharmaceutical and biotech clients
Domain
Life Sciences / Clinical Trials / Contract Research Organization (CRO)
Required skills
Leadership and team management, Clinical trials monitoring (remote and on-site), Regulatory compliance (ICH/GCP, FDA), Data evaluation, Process improvement, Risk-based monitoring
Preferred skills
FSP experience, Strategic planning, Business development
Technologies
Activate, CTMS, Preclarus, Clarity
Responsibilities
Manage staff including coaching, mentorship, performance appraisals, and recruitment; Deliver training on SOPs and WPDs; Ensure adherence to ethical and regulatory standards; Handle system reviews for metrics and KPIs; Facilitate quality assurance audits; Collaborate on strategic planning and business development.
Seniority
Senior, hands-on IC