Clinical Trial Management Principal

Role Summary

The Clinical Trial Management Principal is responsible for leading global or regional-based activities on complex clinical trials across a range of study phases (Phases 1 through 4, including Real World Evidence trials) and therapeutic areas. In the global role, the Clinical Trial Management Principal leads the global cross-functional Study Team, ensuring that deliverables are met, quality is maintained throughout the lifecycle of the trial, and the study budget is maintained. The role is also responsible for contributing to Clinical Trial Management department initiatives, often as leader.

Responsibilities

• Accountable for execution of assigned clinical trial(s) at the global or regional level, according to agreed operational strategy
• Coordinates internal and external clinical trial management activities of all assigned study team members involved in the study planning, start up, conduct, and closure of assigned clinical trials or study regions
• Assists Clinical Operations Program Lead (COPL) or global Clinical Operations Study Lead (gCOSL) in the development of operational strategy and initial timeline
• Creates detailed study timeline with minimal support; monitors progress of timeline with cross-functional Study Team input
• Drives study level operational strategy, oversees development and execution of study operational plan(s)
• Authors study documentation and patient recruitment materials
• Drives cross-functional vendor identification and set up and ensures appropriate ongoing oversight, including invoicing
• Responsible for global clinical trial budget for assigned trial(s) and proactively identifies and manages any anticipated cost overruns
• Manages ongoing vendor invoice reconciliation and scope of work review; works cross-functionally to initiate vendor contract changes and review revised scope of work and budgets
• Takes lead role in investigator identification and selection
• Contributes significantly to the development of study documentation including clinical trial protocols and clinical study reports
• Proactively identifies study risks and implements contingency plans with minimal supervision
• Organizes/hosts and presents at Investigator Meetings and Site Engagement Meetings
• Travels to investigational sites, as requested, to develop relationships with site personnel
• Participates in cross functional study data review where appropriate
• Prepares weekly study operational dashboards for senior executives and regularly presents global study status to senior executives
• Represents Clinical Trial Management department as a technical resource in cross-functional initiatives or process improvement efforts (e.g., SOP and WI updates), often as leader
• Acts as a resource for Clinical trial management staff with less experience
• May function as representative for Clinical Trial Management on vendor-related Joint Operating Committees

Knowledge

• Strong clinical trial management track record showing clear proficiency in project management skills, cross-functional study operations and vendor management
• In-depth understanding of GCP, CFR and ICH Guidelines
• Demonstrates detailed understanding of clinical protocol, intended study populations and drug development
• Demonstrates ability to effectively interface with key medical personnel at investigational site(s)
• Excellent interpersonal skills and communications skills to explain difficult information and works to build alignment
• Ability to effectively problem solve within a cross-functional team
• Demonstrates ability to effectively manage issue identification and resolution
• Excellent attention to detail
• Ability to work successfully under pressure with tight timelines
• Proficiency in Microsoft Office applications including Outlook, Excel, Word, and PowerPoint
• Periodic travel to research sites and investigator meetings

Education

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