Clinical Monitoring Manager

The Clinical Monitoring Manager is responsible for setting up and overseeing the Clinical Research Associates (CRAs) in AMER, meeting deliverables, developing procedures and processes, and assuring collaboration on global monitoring initiatives.

• Work with CRO to identify and hire sufficiently experienced vendor CRAs (this position will not manage any direct reports);
• Responsible for creating/maintaining relationships with CRO's;
• Responsible for supporting, onboarding, training, and the performance of vendor CRAs, providing accurate feedback in a timely manner;
• Continuously assess CRA workload and resource needs for ongoing and future studies, ensuring efficient utilization and project coverage;
• Work closely with Clinical Operations management as a Subject Matter Expert (SME) to educate, train, and empower CRAs, clinical project managers, and study teams to utilize and work efficiently within the monitoring process;
• Perform co-monitoring visits with CRAs as needed to ensure the monitoring process, protocol, and procedures are correctly understood and applied;
• Through close collaboration with Clinical Affairs global leadership, help ensure global alignment regarding monitoring processes and sharing of best practices;
• Work with Clinical Affairs global leadership to identify and lead monitoring process improvement and initiatives including developing, implementing, and streamlining of remote and centralized monitoring strategies;
• Review Monitoring reports and follow-up letters, helping the study team resolve quality issues related to monitoring deliverables;
• Develop and maintain a working knowledge of local and global regulatory requirements and standards (e.g., FDA, ISO14155, ICH-GCP, EU MDR) and country-specific regulatory requirements that impact clinical studies;
• Work with study teams to develop study-related documents and training materials (e.g., CIP, IB, CRF Specifications, Study-specific IC Template, Progress Report, Training Plan, Audit Plan, Monitoring Plan, Clinical Study Overview Presentation);
• Participate in external, study team, and global monitoring meetings;
• Assist in the preparation for audits and inspections and in responding to any questions or findings;
• Perform spot checks of TMF documentation or any other document/activity; and
• Provide support for other clinical study and leadership initiatives, as needed.

Educational Background:

• Bachelor’s degree (preferably in life science, nursing, pharmacy related field) or similar experience within science, healthcare or quality;

• Extensive prior experience in a similar role with a proven track record of successfully leading and executing clinical trial monitoring activities, preferably with at least 3 years of experience as lead CRA or 2 years of experience as Monitoring Manager;

• Sound knowledge of GCP and global medical device regulations, with experience working on medical device studies highly preferred.

Personal Qualifications:

• Experience developing and managing monitoring systems, frameworks, and tools; 

• Proficient at utilizing clinical management systems and electronic data capture systems;

• Strong experience managing individuals;

• Experience in global CRI/ vendor management;

• Bring an operational-experience mindset, critical thinking, and make data-driven decisions;

• Detail oriented, critical thinker, and independent problem-solving skills;

• Proficient working in a fast-paced environment while maintaining high attention to detail, quality, and accuracy;

• Excellent written, listening, and verbal communication skills, with ability to influence outcomes;

• Able and desire to work in a collegial team atmosphere; 

• Willing and able to travel as needed; and

• Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

Cover Letter: For full consideration for this role, please ensure that you include a cover letter with your resume highlighting how your work background relates to this position, as well as why you are interested in working at Cook.