Director of Projects, Clinical Assessment Training and Surveillance (CATS)

Director of Projects, Clinical Assessment Training and Surveillance (CATS)

What you will do

• Engages with senior management to establish strategic department initiatives and objectives
• Drive new QMD developments, including authoring and reviewing QMD documents and guidance documents
• Active participant in the identification and development of new service arms, Active participant in the improvement of existing service arms
• Drive business development activities for CAT, including proposals input, participation in capabilities and bid defense activities
• Identify clinical needs for upcoming and current projects, track and review with CAT Clinical Staff and CAT Leadership
• Accountable for the development of assessment training content and plans by ensuring the training curriculum and materials (including training videos) meet protocol, copyright holder, author, and sponsor requirements

What you will bring to the role

• Strong organizational skills, detail- and service-oriented, with excellent management skills
• Strong understanding of best business practices with respect to rater training, methodologies, and corporate discipline
• Personality focused on meeting timelines consistently and being able to effectively work under pressure
• Excels in writing and verbal communication skills in order to clearly and concisely present information
• Ability to handle multiple tasks and many administrative details in a fast-paced and constantly changing environment
• Clear ability to proactively identify and escalate potential project issues to appropriate CAT and Worldwide staff
• Strong proficiency in all MS-Office applications including Microsoft Word, Excel, Teams, and PowerPoint

Your experience

• Minimum of earned Master’s Degree in life sciences or equivalent
• At least 10 years clinical trial experience with clinical assessments, independently organizing and conducting projects, and presenting at Investigators’ Meetings or similar presentations as expert clinicians
• Preferred at least 4 years of experience managing team members or providing direct clinical mentorship
• Strong applied knowledge of pivotal efficacy measure administration conventions that can be used in the administration and review of such instruments and communicated to train assessors
• Knowledge of operational aspects regarding Phase I-IV clinical research trials and experience working with a Contract Research Organization/Rater Training Organization
• Excellent collaborative skills and ability to work cross-functionally to drive projects and initiatives
• Strong ability to apply knowledge and utilize available resources to develop new ideas and improve existing processes
• Excellent knowledge of SOPs, ICH/GCP/regulatory guidelines
• Competent working with data and numbers
• Willingness to travel

We love knowing that someone is going to have a better life because of the work we do.

To view our other roles, check out our careers page at Worldwide. For more information on Worldwide, visit Worldwide, or connect with us on LinkedIn.

Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.