Assist and provide leadership in managing monitoring related activities for multiple clinical
research studies across with SJM CRMD. Oversee and coordinate operational aspects of ongoing
clinical study projects to ensure FDA/GCP/ICH requirements. This also includes direction into
investigational plan development of future clinical trials conducted by St. Jude Medical-CRMD.
Develops departmental and interdepartmental policies and procedures pertaining to clinical
studies and programs for St. Jude Medical-CRMD. Supervise and mentor clinical monitoring
employees and provide strategic direction for upcoming projects.
• Provide a leadership role in managing/monitoring multiple IDE/NSR clinical research trials
across all SJM Division areas.
• Oversee and coordinate the operational aspects of ongoing projects to ensure meeting
corporate goals on time, cost, and quality performance expectations.
• Assure that clinical trials are monitored on time and to meet all aspects of FDA/GCP
• Assess resource needs with functional FCRAs. Monitor ongoing resource needs.
• Develop specific monitoring Standard Operating Procedures (SOPs) with functional areas. .
• Develop Monitoring Plans for IDE, PAS, and NSR studies.
• Liaise with Clinical Auditing to assure adherence to GCPs; maintenance of SOPs and
internal/external audits are communicated.
• Assist/lead with the hiring for new FCRAs.
• Reports monitoring progress, issues, and scope of work considerations to Senior Management.