Senior Director of Clinical Projects, Clinical Assessment Technologies

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Collaborate with senior management to define strategic departmental goals and initiatives.

• Responsible for the clinical team's key performance indicators (KPIs) and related metrics.

• Identify process improvement opportunities and coordinate initiatives to support these efforts.

• Lead the development of new quality management documents (QMD), including the creation and review of QMD and guidance documents.

• Establish and lead CAT committees to advance initiatives.

• Actively engage in the identification and formulation of new service areas.

• Participate in the enhancement of existing service areas.

• Drive business development efforts for CAT, including input on proposals, involvement in capabilities presentations, and participation in bid defense activities.

• Engage in both internal and external marketing initiatives.

• Act as an external representative for CAT.

• Provide oversight, training, and support for the clinical team.

• Actively participate in the protocol development process, including research, literature reviews, assessment reviews, and risk assessments.

• Identify clinical needs for current and upcoming projects, tracking and reviewing them with CAT Clinical Staff and Leadership.

• Manage resources for CAT study projects as Resource Manager.

• Responsible for all contracted clinical activities in clinical trials.

• Provide clinical expertise and review clinical plans and training materials for CAT-awarded trials.

• Oversee the creation of assessment training content and plans, ensuring that training materials (including videos) comply with protocol, copyright holder, author, and sponsor requirements.

• Serve as a Subject Matter Expert (SME) for CAT clinical activities, offering guidance on therapeutic areas and assessments.

• Provide clinical expertise regarding measurement administration and scoring conventions.

• Support scale acquisition efforts, including versioning of scales.

• Accountable or consulted, based on study assignment, on the creation of source documents to ensure alignment with study protocols.

• Lead the development of data surveillance plans and oversee their implementation throughout trials.

• Accountable for reports to CAT sponsors and teams.

• Directly manage clinical staff.

• Oversee the vetting, hiring, and onboarding processes for new clinical staff.

• Supervise the coordination and execution of onboarding and mentoring tasks.

• Manage CAT study deliverables from initiation to closeout.

• Ensure CAT Clinical staff maintain a state of inspection readiness at all times.

• Contribute significantly to strategic departmental, sponsor-related, and cross-functional initiatives.

• Collaborate with CAT staff, Project Management, and Contracts on study budget formulation, including Work Orders, Letters of Intent, Change Orders, and Change Notification Forms.

• Drive research activities, including data analysis, white papers, posters, and related contributions.

• Utilize advanced knowledge of industry regulations, GCP, and ICH guidelines to ensure full operational and clinical compliance during clinical trial execution.

• Perform additional duties as assigned.

⛳️ Requirements

• Master’s degree in life sciences or equivalent qualification.

• Minimum of 10 years of clinical trial experience with clinical assessments, including independently organizing and conducting projects and presenting at Investigators’ Meetings or similar venues as an expert clinician.

• Preferred at least 4 years of experience in managing team members or providing direct clinical mentorship.

• Strong applied knowledge of pivotal efficacy measure administration conventions and the capability to train assessors.

• Familiarity with operational aspects of Phase I–IV clinical research trials and experience with a Contract Research Organization or Rater Training Organization.

• Excellent collaboration skills and the ability to work cross-functionally to advance projects and initiatives.

• Strong problem-solving and critical thinking abilities.

• Proven ability to leverage knowledge and resources to generate new ideas and enhance existing processes.

• Comprehensive understanding of SOPs, ICH/GCP, and regulatory guidelines.

• Proficiency in data handling and numerical analysis.

• Fluency in English, encompassing reading, writing, and speaking, for daily business operations.

• Willingness to travel domestically and internationally for key meetings, with flexibility to accommodate global time zones as necessary.

🏝️ Benefits

• Competitive benefits package based on location.

• Transparent compensation.