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

What the Business Development Operations Department does at WorldwideBusiness 

Development Operations is a team of highly experienced Business Development professionals who drive significant bookings targets and support Worldwide’s strategic position in a competitive market through a culture of collaboration and innovation.  

This tenured team supports a strong portfolio of existing business as well as being responsible for the continued significant growth of Worldwide’s future pipeline and sponsors. The team is accountable for overall sales performance, the profitable achievement of sales goals, and for aligning sales objectives with the Worldwide’s therapeutic and commercial strategies. 
 

What you will do 

• 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 

What you will bring to the role 

• 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 

Your experience 

• 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 required 

• 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 required. This position requires strong knowledge of monitoring practices, demonstrated knowledge / competence in the application of CFRs, GCPs and ICH guidelines