Senior Director of Clinical Projects, Clinical Assessment Technologies
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Job Description
Director of Clinical Projects overseeing clinical activities and leading initiatives for Worldwide Clinical Trials. Responsible for mentoring teams and ensuring compliance with guidelines while driving improvements.
Responsibilities:
- Engage with senior management to establish strategic departmental initiatives and objectives
- Accountable for clinical team key performance indicators (KPIs) and associated metrics
- Drive identification of process improvement needs and coordinate initiatives to support these activities
- Lead new quality management document (QMD) developments, including authoring and reviewing QMD and guidance documents
- Create and lead CAT committees to further initiatives
- Actively participate in the identification and development of new service arms
- Actively participate in the improvement of existing service arms
- Drive business development activities for CAT, including proposal input, participation in capabilities presentations, and bid defense activities
- Participate in internal and external marketing activities
- Serve as an external spokesperson for CAT
- Provide oversight, training, and support for the clinical team
- Actively engage in the protocol development process, including research, literature review, assessment review, and risk assessment
- Identify clinical needs for upcoming and current projects, and track and review them with CAT Clinical Staff and Leadership
- Resource CAT study projects as Resource Manager
- Accountable for all contracted clinical activities in clinical trials
- Provide clinical expertise and review of clinical plans and training content for CAT-awarded trials
- Oversee development of assessment training content and plans, ensuring training curriculum and materials (including videos) meet protocol, copyright holder, author, and sponsor requirements
- Serve as Subject Matter Expert (SME) for CAT clinical activities, including therapeutic area and assessment advisement and guidance
- Provide clinical expertise on measurement administration and scoring conventions
- Support scale acquisition activities, including scale versioning
- Accountable or consulted, depending on study assignment, on source document creation to ensure materials align with study protocols
- Lead development of data surveillance plans and oversee execution of data surveillance throughout trials
- Accountable for CAT sponsor and team reports
- Manage clinical staff directly
- Lead vetting, hiring, and onboarding of new clinical staff
- Oversee coordination and execution of onboarding and mentoring assignments
- Oversee CAT study deliverables from launch through study closeout
- Ensure CAT Clinical staff operate in a constant state of inspection readiness
- Contribute significantly to strategic departmental, sponsor-related, and cross-functional initiatives
- Collaborate with CAT staff, Project Management, and Contracts on study budget development, including Work Orders, Letters of Intent, Change Orders, and Change Notification Forms
- Drive research activities, including data analysis, white papers, posters, and related contributions
- Apply advanced knowledge of industry regulations, GCP, and ICH guidelines to ensure full operational and clinical compliance during clinical trial conduct
- Perform other duties as assigned
Requirements:
- Master’s degree in life sciences or equivalent
- At least 10 years of clinical trial experience with clinical assessments, including independently organizing and conducting projects and presenting at Investigators’ Meetings or similar forums as an expert clinician
- Preferred minimum of 4 years of experience managing team members or providing direct clinical mentorship
- Strong applied knowledge of pivotal efficacy measure administration conventions and the ability to train assessors
- Knowledge of operational aspects of Phase I–IV clinical research trials and experience working with a Contract Research Organization or Rater Training Organization
- Excellent collaboration skills and ability to work cross-functionally to drive projects and initiatives
- Strong problem-solving and critical thinking skills
- Demonstrated ability to apply knowledge and utilize resources to develop new ideas and improve existing processes
- Excellent knowledge of SOPs, ICH/GCP, and regulatory guidelines
- Competence in working with data and numerical analysis
- Fluency in English, including reading, writing, and speaking, for daily business operations
- Ability to travel domestically and internationally to attend key meetings, with flexibility to accommodate global time zones as needed
Benefits:
- Competitive benefits package depending on location
- Transparent compensation
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