Associate Director, Operations – Clinical Assessment Technologies

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

📋 Description

• Assess operational requirements for future projects, monitor and evaluate ongoing tasks for CAT Operations personnel.

• Serve as Resource Manager for CAT study projects.

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

• Provide operational oversight for specified CAT study projects.

• Coordinate and engage in resource allocation activities for all CAT awarded projects.

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

• Proactively identify and participate in process enhancement initiatives.

• Take part in QMD evaluations and the development of new QMDs.

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

• Organize and oversee meetings for the CAT Operations team.

• Provide active engagement and oversight of study risk assessments in relation to operational activities.

• Collaborate with department leaders to ensure alignment between CAT operational services and clinical offerings.

• Lead and/or support departmental initiatives aimed at implementing policies, methods, and techniques to enhance existing service areas and promote departmental growth.

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

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

• Assist with vendor management issues, including participation in escalations, Vendor Management, and Quality Assurance meetings.

• Evaluate and monitor ongoing budget utilization and revenue recognition with Operations Managers to ensure projects achieve financial objectives.

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

• Play a key role in various strategic departmental, sponsor-related, and cross-functional initiatives.

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

• Utilize comprehensive knowledge of industry regulations and guidelines to ensure operational compliance throughout clinical trial processes.

⛳️ Requirements

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

• Strong leadership, management, and interpersonal abilities.

• Excellent planning and organizational capabilities.

• A minimum of 7+ years of clinical trial experience, including at least 4 years in global clinical trials.

• Preferred experience of at least 5+ years in team management or project management roles.

• Practical experience managing all aspects of global clinical trials is essential.

• Prior experience in psychiatry/CNS therapeutic areas is advantageous.

• Effective leadership skills with a demonstrated ability to create and maintain high-performance team productivity and cohesion are required.

• This role necessitates a strong understanding of monitoring practices, as well as demonstrated knowledge and proficiency in the application of CFRs, GCPs, and ICH guidelines.

🏝️ Benefits

• Health insurance.

• 401(k) matching.

• Flexible working hours.

• Paid time off.

• Opportunities for professional development.