The Position

Contributes to the successful execution of clinical trials through driving the performance of clinical trial sites with cross-functional coordination and communication for assigned trials. Supports process improvement and innovation projects.

Relationships

Reports to a Senior Manager level (or above). Builds relationships with internal stakeholders relevant to the planning and execution of clinical trials (e.g., across US Operations, US Clinical, Medical & Regulatory Affairs (CMR), HQ Research & Development (R&D). Builds relationships with external partners relevant to the planning and execution of clinical trials (e.g., clinical sites, health care/research networks, vendors, etc.).

Essential Functions

• Oversees clinical site performance and ensures consistency in site management for assigned trials by providing support and guidance to CRAs and In-House CRAs, including review of monitoring visit reports, site metrics, and data trends to ensure quality and compliance
• Coordinates and drives site start-up/activation activities, including the deployment of Site Selection Visit (SSV)/Site Initiation Visit (SIV) training tools and materials
• Drives US monitoring activities in accordance with the Monitoring Plan as well as Risk-Based Quality Management (RBQM) principles including coordination of deliverables for database lock (DBL) and site/trial closure
• Supports internal audits and health authority inspections in collaboration with the Trial Manager, including inspection readiness activities and the development of corrective/preventative action plans
• Develops trial-level site communications inclusive of key updates and information

Physical Requirements

20-30% overnight travel required.

Qualifications

• Bachelor’s degree or Registered Nurse (RN) degree/diploma required
• Minimum of 6 years’ experience in the planning, and conduct of GCP clinical trials, including at least 4 years of direct site management and logistical clinical trial execution in the pharmaceutical industry (Pharma/Biotech/CRO) required
• On-site monitoring experience preferred
• Strong understanding of International Council for Harmonisation Good Clinical Practice (ICH-GCP) principles and the application of those principles to trial planning and execution required
• Excellent communications skills (verbal, written, presentation) in English
• Demonstrated collaborative and stakeholder management skills
• Foundational skills in designing and implementing innovation/improvement initiatives, including the required change management