Senior Manager, Clinical Monitoring

Role Overview

• Supports global and regional Clinical Trial Operations (CTO) and Clinical Monitoring management
• Manage Clinical Research Associates (CRA) and lead the development of processes, procedures, and tools/templates related to monitoring and site management activities
• Develop and implement strategy for in-house, regional monitoring activities on assigned studies
• Lead monitoring activities on assigned studies
• Author or review Clinical Monitoring Plan in collaboration with CTO and ensure CRA compliance
• Manage the CRA monitoring visit schedule
• Review and finalize visit reports for regional CRAs
• Track status of action items and queries
• Support CRAs and CTO with the implementation of site corrective actions
• Track and report to study team and leaders on compliance, trends, and metrics
• Manage conduct of monitoring oversight visits (MOVs) with CRO CRAs
• Mentor Associate Managers and Managers of Clinical Monitoring
• Conduct annual performance assessment activities including appraisals, salary recommendations, and promotion justifications
• Lead development and improvement of department processes, best practices, and tools and templates

Requirements

• BS in biological sciences or related discipline
• at least 8 years of experience working in the biotechnology/pharmaceutical industry
• Experience in endocrine disorders preferred
• A minimum of 5 years in a supervisory role
• Strong understanding of clinical trial processes, protocols, and medical terminology
• experience using risk-based monitoring processes strongly preferred
• Previous experience as a Lead CRA, Trial Manager, or equivalent strongly preferred
• Demonstrates critical thinking, root cause analysis and problem solving
• An understanding and demonstrated application of Good Clinical Practices, ICH Guidelines and regulatory requirements
• In-depth experience with cross-functional drug development with prior regulatory inspection experience preferred
• Excellent writing skills as they relate to the preparation of clinical trial documents
• Excellent interpersonal skills with strong oral/written communication and presentation skills
• Excellent negotiation skills and a tactful approach that leads to high value on services obtained and outcomes achieved
• Demonstrated leadership and management skills
• Good judge of risks and a keen ability to analyze options and manage outcomes
• Well-versed with the latest trends in the clinical trial industry.

Benefits

• health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance
• 20 days of PTO
• 10 paid holidays
• winter company shutdown
• discretionary annual target bonus
• stock options
• ESPP
• 401k match