Overview

The Director, Clinical Monitoring serves as a leader within the Clinical Affairs function and is responsible for defining and overseeing all aspects of Clinical Monitoring operations globally. This position includes ensuring that the are met, assessing functional resourcing needs, and developing policies, procedures, and processes.

Responsibilities

• Manage all aspects clinical study monitoring, including: allocation of resources, assessment of new and/or potential monitors, onboarding and training, evaluation and oversight of monitoring vendors, review and approval of monitoring reports, resolution of monitoring issues, etc

• Direct strategy and oversight for execution of activities regarding on-site monitoring, remote monitoring, and centralized monitoring

• Regional oversight of internal monitoring employees and external monitoring vendors

• Collaborate with regional Clinical Affairs leadership to align monitoring activities globally, ensuring execution of monitoring-related training and expectations (e.g. expectations for reviewing monitoring reports, working with monitors etc.) for Clinical Affairs employees

• Work cross functionally with the Clinical Affairs teams that have centralized monitoring aspects, to implement a risk-based approach to monitoring, including managing the development and maintenance of clinical monitoring procedures and tools. Ensure collaboration around key areas of risk and enable oversight of risk tolerances

• Collaborate with clinical to create and/or review pertinent study documentation and training materials (e.g., Monitoring Plan, Risk Management Plan, etc.)

• Assist in the preparation for, and participation in, site/study audits and inspections

• Perform and maintain proficiency in all core monitoring responsibilities

• Develop and maintain a working knowledge of local and global regulatory requirements and standards (e.g., FDA 21 CFR 11/50/54/56/812, ISO14155, ICH-GCP, EU MDR) and country-specific regulatory requirements that impact clinical studies

• Awareness of FDA and MDCG industry guidance pertaining to monitoring and study conduct (e.g., “A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Guidance for Industry (April 2023)”

• Encourage and foster employee development through mentorship and training

• Provide leadership in accordance with company policies, procedures, applicable laws and regulations that apply to your business activities

• Work closely with both process and project management to determine priorities and ensure that project objectives are met

• Work with HR to recruit, interview, select, hire, and orient new employees

• Plan and allocate resources to effectively staff and accomplish work to meet functional and company expectations for productivity and quality goals;

• Foster an environment where the giving and receiving of feedback is encouraged

• Facilitate the annual employee performance review process coordinated by HR. Encourage employee contributions through goal setting, feedback and performance development planning

• Consult HR to document, administer and resolve employee disciplinary action if required

• Maintain ongoing communication with employees through team meetings, one-on-one meetings, email, and other appropriate forms of communication

• Review and approve employee requests through appropriate pathways and according to company policies (e.g. expense reports, purchase orders, PTO approval, education and tuition assistance, and hardware/software workflows)

• Establish trusted relationships with Cook colleagues, management, and external stakeholders by providing respectful, mindful and purposeful communication and maintaining a commitment to exceeding expectations;

• Understand, practice and model the principles of honesty and integrity as outlined in the Cook Global Code of Conduct

Qualifications

• Bachelor’s degree in life science or medical health or other professional qualifications equivalent to a university degree required;

• Minimum of 12 years prior experience in clinical research, including at least 5 years with medical devices;

• 6 years’ experience as a CRA, with 2 years’ experience as a lead CRA, including management responsibilities;

• Strong understanding of Clinical Monitoring requirements, processes (e.g., clinical study design and execution), budgets, and operations

• Strong working knowledge of US federal regulations related to clinical research studies, ICH Guidelines and GCP;

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

• History of successfully managing multiple projects, responsibilities, and deadlines;

• Sufficiently assertive to deal with confrontational situations while recognizing the need to communicate in an effective and diplomatic manner, and work as a member of the team;

• Excellent organizational, leadership and problem-solving skills;

• Excellent listening, written and verbal communication skills; Ability and desire to work in a collegial team atmosphere; including communicating and working constructively with colleagues; and

• Willing and able to travel as needed.

• Attention to detail with excellent documentation skills and ability to continuously anticipate and solve problems using poise and effective interpersonal skills, with a team-oriented approach

• Ability to handle multiple tasks and meet deadlines while delivering high quality work in a dynamic environment