Brenda Keiser

 Provided strategic direction for field-based Clinical Research Monitoring, overseeing pivotal study resourcing and monitoring expertise.  Managed Monitoring operations for clinical trials in Canada, exceeding predefined KPIs and optimizing resource allocation for operational efficiency.  Led monitoring efforts across Surgical, Robotics, and Respiratory trial domains, ensuring milestone achievements such as inaugural US enrollments, audit success, and smooth FDA data submissions.  Cultivated a high-performance environment, nurturing individual growth trajectories and recognizing notable achievements to maintain a motivated workforce.  Mentored team members for career progression, facilitating transitions into roles of greater responsibility such as Supervisory and Lead Monitor positions, while coaching a co-manager for success.  Collaborated seamlessly across clinical functions, including Data Solutions, Safety, and Payments, fostering a cohesive approach to achieve shared objectives.  Successfully navigated resource challenges during a divestiture phase, ensuring operational continuity and securing future work prospects with minimal disruption.  Led improvement initiatives for Medtronic Operating Systems within the Monitoring group, implementing harmonized SOPs, and standardized tools, enhancing report completion timeliness, and streamlining travel approval processes.

 Managed Clinical Monitoring for the Surgical and Peripheral Vascular businesses, achieving 100% compliance with training and study-specific milestones within corporate timelines.  Conducted Performance Evaluations, Development Plans, and Goal setting for eight (8) full-time Clinical Monitors.  Executed Lead Monitor activities and fostered relationships with investigative sites, including selection, initiation, training, and ongoing communication to ensure adherence to protocols and timelines.  Played a crucial role in Medtronic/Covidien integration activities, minimizing disruption to Field Monitors and study teams, driving Integration Workstreams, and directing the Harmonization of Clinical Trial Monitoring Systems and Documents.

 Managed Lead responsibilities for Surgical Stapler and Respiratory studies, maintaining oversight and reporting metrics to the Global Director of Clinical Field Monitoring  Assist in the development and review of study documents, including protocols, informed consent forms, and study manuals.

 Conducted monitoring activities for Spinal, Pulmonary Adhesion, and Cranial Sealant Systems, and Wound Closure Staplers  Collaborated closely with cross-functional teams to address compliance issues and improve trial performance.  Compiled and reported comprehensive data and metrics related to trial compliance, safety, and performance.

 Conducted site visits and coordinated monitoring activities, ensuring strict compliance with protocols and clinical objectives.  Proposed and negotiated budgets for various clinical investigations.  Prepared comprehensive clinical reports essential for regulatory submissions, presentations, monographs, and publications.