Program Manager, Clinical Monitoring, AMER

Overview

The Program Manager for Clinical Monitoring in AMER at Cook Research Incorporated 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.

Responsibilities

• 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.

• Provide support for other clinical study and leadership initiatives, as needed.

Qualifications

Educational Background:

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

• Proven record and at least 10 years of experience as CRA in various study stages (e.g., study start up activities, enrollment and follow-up, and study close-out), monitoring activities, and insight into project management, preferably with 3 years of experience as lead CRA or 2 yars of experience as Monitoring Manager

• Knowledge of applicable international standards and other regulatory requirements that may impact clinical studies

Personal Qualifications:

• Able to lead and motivate with a positive mindset;

• Able to see studies from the HCPs', patients' and sites' perspective;

• Conscientious, influential person with an outstanding work ethic and strong personal discipline;

• Willing and capable to handle multiple sites/studies/responsibilities;

• Sufficiently assertive to deal with confrontational situations;

• Excellent organizational, leadership, critical thinking, and problem-solving skills;

• Highly self-motivated;

• Excellent written, listening, and verbal communication skills, including presentation skills;

• Able and desiring to work in a collegial team atmosphere; including communicating and applying conflict management and resolution skills;

• Willing and able to travel up to 60%; 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.