Clinical Trial Strategy and Delivery Principal

Vertex Inc.•Boston, MA

3d•Remote

About The Position

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.

Requirements

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.

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