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Cook Medical · 1 month ago

Clinical Monitoring Manager

US-IN-West Lafayette

Full-time

Onsite

Mid, Senior Level

3+ years exp

Cook Research Inc. is a company focused on clinical research, and they are seeking a Clinical Monitoring Manager. This role is responsible for overseeing Clinical Research Associates, ensuring efficient project coverage, and collaborating on global monitoring initiatives.

HardwareManufacturingMedical Device

No H1B

U.S. Citizen Only

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; and

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

Qualification

Clinical trial monitoringGCP knowledgeVendor managementClinical management systemsElectronic data captureCritical thinkingProblem-solvingCommunication skillsAttention to detail

Required

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

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

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

Company

Cook Medical

Glassdoor3.6

Cook Medical is a medical device company that specializes in designing, manufacturing, and delivering invasive medical devices. It is a sub-organization of Cook Group.

Founded in 1963

Bloomington, Indiana, USA

10001+ employees