Associate Director, Operations - Clinical Assessment Technologies; CAT - US​/Canada - Remote

Business Development Operations Department Overview

The Business Development Operations team is a highly experienced group driving significant booking targets and supporting Worldwide’s strategic position in a competitive market through collaboration and innovation. The team supports the growth of Worldwide’s future pipeline and sponsors, and is accountable for overall sales performance, profitable achievement of sales goals, and aligning sales objectives with the company's therapeutic and commercial strategies.

• Identify operational needs for upcoming projects and track and review current assignments for CAT Operations staff
• Resource CAT study projects as Resource Manager
• Engage as Subject Matter Expert (SME) for CAT Operations activities
• Provide operational oversight for designated CAT study projects
• Engage in and coordinate resourcing activities for all CAT awarded projects
• Identify training and skills gaps among staff; coordinate learning opportunities to enhance operational staff knowledge of industry regulations, processes, materials, and guidelines
• Actively identify and engage in process improvement activities
• Participate in QMD reviews and new QMD development
• Author, collaborate, and review QMD documents and guidance documents
• Coordinate and manage CAT Operations team meetings
• Active engagement and oversight of study risk assessments, as they relate to operational activities
• Work with department leaders to ensure alignment among CAT operational and clinical services
• Lead and/or contribute to departmental initiatives that implement policies, methods, techniques to contribute to existing service areas and department growth
• Accountable for oversight of CAT study deliverables from launch to study closeout
• Assist and collaborate with Operations staff, Project Management, Contracts on vendor and study budget development, scope of work revisions, tracking, and compliance
• Assist in vendor management concerns, including involvement with escalations and Vendor Management/Quality Assurance meetings
• Review and assess ongoing budget utilization and revenue recognition with Operations Managers to ensure projects meet financial targets
• Manage internal CAT operations meetings and other trial‑specific meetings as appropriate
• Significant contributor to multiple strategic departmental, sponsor‑related and cross‑functional initiatives
• Participate in business development activities including proposals input, capabilities, and bid defense meetings
• Apply thorough knowledge of industry regulations and guidelines to ensure operational compliance during clinical trial conduct

• Exceptional organizational skills, detail‑ and service‑oriented, with excellent management and supervision skills
• Excellent understanding of best business practices with respect to clinical trial operations and rater reliability processes
• Knowledge and capabilities of technology vendors and their abilities
• Excellent at meeting timelines consistently and working under pressure
• Continuously open to constructive feedback
• Exceptional interpersonal skills in a fast‑paced, deadline‑oriented, and changing environment
• Excellent ability to proactively identify and elevate potential project issues to appropriate CAT and WCT staff
• Basic knowledge of statistics and finance practices

• Minimum of a bachelor’s degree, preferably with a Master’s degree (life sciences, MBA and/or PMP certification)
• Strong leadership, management and interpersonal skills
• Strong planning and organizational skills
• At least 7 years clinical trial experience with at least 4 years in global clinical trials
• Preferred at least 5 years managing team members or project management experience
• Hands‑on experience in day‑to‑day management of all aspects of global clinical trials
• Prior experience in psychiatry/CNS therapeutic areas is a plus
• Knowledge and appreciation of all stages of clinical drug development; proven ability to build and foster high‑performance team productivity and cohesiveness; strong knowledge of monitoring practices, CFRs, GCPs, and ICH guidelines

Salary range (United States of America): $ – $ annually. Compensation is determined based on experience, performance, education, and internal equity. A competitive benefits package is available depending on location.