Associate Director, Operations - Clinical Assessment Technologies (CAT) - US/Canada

Worldwide Clinical Trials•Carolina, NC

9d•Remote

About The Position

Worldwide Clinical Trials is a global, midsize CRO that is dedicated to pushing boundaries and innovating to find cures for diseases. The Business Development Operations Department is a team of experienced professionals who drive bookings targets and support the company's strategic position through collaboration and innovation. This team supports existing business and is responsible for pipeline growth, sales performance, and achieving sales goals in alignment with the company's strategies. The Associate Director, Operations - Clinical Assessment Technologies (CAT) will identify operational needs for upcoming projects, manage and review staff assignments, serve as a Subject Matter Expert for CAT Operations, and provide operational oversight for designated CAT study projects. This role involves coordinating resourcing activities, identifying and addressing training needs, participating in process improvement, and authoring/reviewing quality management documents. The position also requires active engagement in study risk assessments, leading departmental initiatives, overseeing CAT study deliverables from launch to close-out, and collaborating on budget development and vendor management. The role contributes to business development activities and ensures operational compliance with industry regulations.

Requirements

Must have a minimum of a bachelor’s degree, preferably with an 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’ experience in global clinical trials
Preferred at least 5+ years of experience 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
The ideal candidate possesses knowledge and appreciation of all stages of clinical drug development.
Effective leadership skills and a proven ability to build and foster high performance team productivity and cohesiveness is .
This position requires strong knowledge of monitoring practices, demonstrated knowledge / competence in the application of CFRs, GCPs and ICH guidelines

Nice To Haves

Exceptional organizational skills, detail- and service-oriented, with excellent management / supervision skills
Excellent understanding of best business practices with respect to clinical trial operations and rater reliability processes
Knowledge and capabilities of our technology vendors and their abilities (skill)
Excels in planning, managing, monitoring, and critiquing skills
Excellent at meeting timelines consistently and being able to effectively work under pressure
Continuously open to constructive, developmental feedback
Exceptional interpersonal skills in a fast-paced, deadline oriented, and changing environment
Excellent ability to proactively identify and escalate potential project issues to appropriate CAT and WCT staff
Basic knowledge of statistics and finance practices

Responsibilities

Identify operational needs for upcoming projects, 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 and assist with learning opportunities to enhance operations staff knowledge and skills of industry related 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 aim to implement polices, methods, techniques to contribute to existing service areas and department growth
Accountable for oversight of CAT study deliverables from Launch process to study close out
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 related concerns, including involvement with escalations, Vendor Management and Quality Assurance meetings
Review and assess ongoing budget utilization and revenue recognition with Operations Managers to ensure projects are meeting 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; but not limited to proposals input, capabilities, and bid defense meetings
Apply thorough knowledge of industry regulations and guidelines to ensure operational compliance during clinical trial conduct