Clinical Trial Management Principal

Job Description

General Summary:

The Clinical Trial Management Principal is responsible for managing single-region trials of high complexity or leading large multi-center global clinical trials across a range of study phases (including real world evidence based studies) and therapeutic areas. The role is also responsible for contributing to Clinical Trial Management department initiatives, often as leader.

Key Duties And Responsibilities

• 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, overseeing development and execution of study operational plan(s)
• Drives cross-functional vendor identification and set up and ensures appropriate ongoing oversight
• Manages approved trial budget(s) including 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, study plans and clinical study reports
• Proactively identifies study risks and implements contingency plans with minimal supervision
• Participates in cross functional study data review where appropriate
• 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 And Skills

• 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
• Approximately 25% travel to research sites and investigator meetings.
  
  

Education And Experience

• Bachelor's degree in life sciences discipline or relevant discipline
• Typically requires 8 years of relevant work experience in the biopharmaceutical industry, or the equivalent combination of education and experience.
  
  

Pay Range

$136,000 - $204,000

Disclosure Statement

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

Flex Designation

Remote-Eligible

Flex Eligibility Status

In this Remote-Eligible role, you can choose to be designated as:

• Remote: work remotely five days per week and come into the office on occasion – you’re always welcome on-site; or select
• Hybrid: work remotely up to two days per week; or select
• On-Site: work five days per week on-site with ad hoc flexibility.
  
  

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com