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

About this role

Who we are

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

Why Worldwide

We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!

What the   Business Development Operations  Department does at Worldwide Business   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

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