[Hiring] Director of Clinical Projects, Clinical Assessment Technologies @Worldwide Clinical Trials

Role Description

The Clinical Assessment Technologies (CAT) department is a team of highly experienced clinicians and operations experts whose purpose is to improve clinical outcomes data by reducing data variability associated with lack of training, inconsistent approaches to scale administration and scoring, placebo response, and incorrect source. The members of CAT have extensive industry-related experience stemming from their time working on the site level for sponsors and other service providers. Additionally, the CAT team has conducted more than 75 international Phase I to Phase IV trials and has trained over 7,000 raters.

• Engages with senior management to establish strategic department initiatives and objectives.
• Drives 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.
• Drives business development activities for CAT, including proposals input, participation in capabilities and bid defense activities.
• Identifies clinical needs for upcoming and current projects, tracks and reviews 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.

Qualifications

• 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.

Requirements

• 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.

Benefits

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