Associate Director, Operations – Clinical Assessment Technologies

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Assess operational requirements for forthcoming projects and monitor current assignments for the CAT Operations team.

• Serve as Resource Manager for CAT study projects.

• Act as a Subject Matter Expert (SME) for CAT Operations activities.

• Provide operational supervision for assigned CAT study projects.

• Participate in and coordinate resource allocation for all CAT awarded projects.

• Identify training and skills deficiencies among staff; facilitate and support learning opportunities to improve the operations team’s understanding of industry-related regulations, processes, materials, and guidelines.

• Proactively identify and engage in initiatives aimed at process improvement.

• Take part in QMD reviews and contribute to the development of new QMDs.

• Write, collaborate on, and review QMD and guidance documents.

• Organize and oversee CAT Operations team meetings.

• Actively participate in and supervise study risk assessments related to operational tasks.

• Collaborate with departmental leaders to ensure coherence between CAT operational and clinical services.

• Lead and/or contribute to departmental projects designed to implement policies, methods, and techniques that enhance existing service areas and promote departmental growth.

• Responsible for overseeing CAT study deliverables from the Launch phase to study completion.

• Assist and collaborate with Operations personnel, Project Management, and Contracts on vendor and study budget formulation, scope of work modifications, tracking, and compliance.

• Aid in vendor management-related issues, including engagement in escalations, Vendor Management, and Quality Assurance meetings.

• Analyze and evaluate ongoing budget utilization and revenue recognition with Operations Managers to ensure that projects meet financial objectives.

• Manage internal CAT operations meetings and other trial-specific meetings as needed.

• Act as a significant contributor to various strategic departmental, sponsor-related, and cross-functional initiatives.

• Engage in business development efforts including, but not limited to, proposal contributions, capabilities presentations, and bid defense meetings.

• Utilize extensive knowledge of industry regulations and guidelines to guarantee operational compliance throughout clinical trial execution.

⛳️ Requirements

• A minimum of a bachelor’s degree is required, with a preference for a Master’s degree in life sciences, an MBA, and/or PMP certification.

• Excellent leadership, management, and interpersonal skills are essential.

• Strong planning and organizational abilities are necessary.

• A minimum of 7 years of experience in clinical trials, with at least 4 years in global clinical trials is required.

• At least 5 years of experience managing team members or in project management is preferred.

• Hands-on experience in the daily management of all aspects of global clinical trials is required.

• Previous experience in psychiatry or CNS therapeutic areas is an advantage.

🏝️ Benefits

• Competitive benefits package tailored to location.

• Commitment to pay equity and transparency.