Clinical Trial Management Principal

Role Summary

Clinical Trial Management Principal is responsible for leading global or regional-based activities on complex clinical trials across a range of study phases and therapeutic areas. In the global role, leads the global cross-functional Study Team, ensuring deliverables are met, quality is maintained, and the study budget is managed. Also contributes to department initiatives, often as a leader.

Responsibilities

• Accountable for execution of assigned clinical trial(s) at the global or regional level according to the operational strategy
• Coordinates internal and external clinical trial management activities of all study team members involved in planning, start up, conduct, and closure
• Assists COPL or gCOSL in developing operational strategy and initial timeline
• Creates detailed study timeline with minimal support; monitors progress with cross-functional input
• Drives study-level operational strategy and oversees development and execution of study operational plans
• Authors study documentation and patient recruitment materials
• Drives cross-functional vendor identification and setup and ensures ongoing oversight, including invoicing
• Responsible for global clinical trial budget for assigned trials and identifies and manages potential cost overruns
• Manages vendor invoice reconciliation and scope of work; initiates vendor contract changes and reviews revised budgets
• Takes lead role in investigator identification and selection
• Contributes to development of study documentation including protocols and clinical study reports
• Identifies study risks and implements contingency plans with minimal supervision
• Organizes/presents at Investigator Meetings and Site Engagement Meetings
• Travels to investigational sites as needed to develop relationships with site personnel
• Participates in cross-functional study data review where appropriate
• Prepares weekly study operational dashboards for senior executives and presents global study status
• Represents the department as a technical resource in cross-functional initiatives or process improvements
• Acts as a resource for staff with less experience
• May serve as the representative for Clinical Trial Management on vendor-related Joint Operating Committees

Knowledge and Skills

• Strong clinical trial management track record with proficiency in project management, cross-functional operations, and vendor management
• In-depth understanding of GCP, CFR, and ICH Guidelines
• Detailed understanding of clinical protocol, study populations, and drug development
• Ability to interface effectively with key medical personnel at investigational sites
• Excellent interpersonal and communication skills to explain difficult information and build alignment
• Effective problem-solving within cross-functional teams
• Ability to manage issue identification and resolution
• Excellent attention to detail
• Ability to work under pressure with tight timelines
• Proficiency in Microsoft Office applications (Outlook, Excel, Word, PowerPoint)
• Periodic travel to research sites and investigator meetings

Education

• Bachelor's degree in life sciences or relevant discipline
• Typically requires 6 years of relevant work experience in the biopharmaceutical industry, or equivalent