As our Manager, Research Operations, you will manage and supervise clinical research staff, ensuring the successful and timely completion of clinical trials and full compliance with all relevant regulations.Every day you will coordinate and monitor all clinical research operational activities, managing trials according to regulations and ICH-GCP guidelines. You will also assist with research approvals, oversee study budgets, manage enrollment/performance, forecast resources, and develop/standardize clinical research policies and procedures.To be successful in this role, you will demonstrate exceptional leadership in clinical research, expertise in regulatory compliance, and a proven ability to manage complex resources and processes to ensure high-quality, compliant trial execution.

• Participates in the planning, performance and management of all clinical trials in compliance with applicable regulations, ICH-GCP guidelines and internal policies. Acts as an administrative resource helping clinicians and other investigators navigate human subjects research approval processes.
• Coordinates and monitors activities of all clinical research operational staff to ensure successful and timely completion of clinical trials. Works also, and when relevant, with program manager(s), to effectively forecast and manage trials financial performance, including nurse and coordinator assignments.
• Collaborates with legal and IP office as necessary in overseeing and approving study budgets and with staff and billing service units to ensure proper allocation of funds to cover expenses specific to trials activity. Monitors enrollment and study performance based upon contract deliverables and works to effectively forecast resource needs to ensure solid performance.
• Organizes clinical research staff orientation and education offerings and actively participates in learning relating to role. Works to develop standardized working instructions across all programs, and develops all clinical research operations policies and procedures. Develops mechanisms to ensure annual reviews of policies are in place. Monitors research activities to ensure compliance with federal, state and local regulations and guidelines.

Required

• Bachelors Other or a combination of education and/or job related experience.
• Minimum of eight (8) years of clinical research experience with a minimum of five (5) years of clinical research management, upon hire