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Clinical Trial Management Principal

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Vertex Pharmaceuticals

2mo ago

  • Job
    Full-time
    Senior & Expert Level
  • Research & Development
    Healthcare
  • Rome
  • Quick Apply

AI generated summary

  • You need strong clinical trial management skills, GCP/ICH knowledge, excellent communication, problem-solving abilities, attention to detail, and a life sciences degree with relevant experience.
  • You will oversee clinical trial execution, manage timelines and budgets, coordinate study teams, author documentation, and engage with vendors and investigators while presenting status updates to executives.

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

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

FAQs

What is the main responsibility of a Clinical Trial Management Principal?

The main responsibility of a Clinical Trial Management Principal is to lead global or regional activities on complex clinical trials across various study phases and therapeutic areas, ensuring deliverables are met, quality is maintained, and the study budget is adhered to.

What kind of trials will the Clinical Trial Management Principal oversee?

The Clinical Trial Management Principal will oversee complex clinical trials across a range of study phases, including Phases 1 through 4 and Real World Evidence trials.

What qualifications are required for this position?

A Bachelor's degree in a life sciences discipline or a relevant field is required, along with extensive relevant work experience in the biopharmaceutical industry or an equivalent combination of education and experience.

Is there any travel involved in this position?

Yes, there may be periodic travel to research sites and investigator meetings.

What skills are necessary for a Clinical Trial Management Principal?

Necessary skills include strong project management capabilities, in-depth understanding of GCP, CFR, and ICH Guidelines, excellent interpersonal and communication skills, attention to detail, and proficiency in Microsoft Office applications.

How does Vertex facilitate work arrangements for this role?

This role is Remote-Eligible, meaning you can choose to work remotely five days per week, hybrid (up to two days remote), or on-site five days with ad hoc flexibility.

What is the company culture regarding diversity and inclusion at Vertex?

Vertex is committed to equal employment opportunity and non-discrimination, embracing diversity in its workforce and ensuring a work environment free from discrimination based on various characteristics protected under applicable law.

Will the Clinical Trial Management Principal need to manage vendor relationships?

Yes, the role includes responsibilities for cross-functional vendor identification, setup, ongoing oversight, and managing vendor invoice reconciliation.

What role does the Clinical Trial Management Principal play in team dynamics?

The Clinical Trial Management Principal coordinates internal and external clinical trial management activities involving all assigned team members and acts as a resource for Clinical trial management staff with less experience.

How does this position contribute to the Clinical Trial Management department initiatives?

The Clinical Trial Management Principal contributes significantly to department initiatives, often taking a leadership role in process improvement efforts such as SOP and WI updates.

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Vertex Pharmaceuticals

The Science of Possibility

Science & Healthcare
Industry
1001-5000
Employees
1989
Founded Year

Mission & Purpose

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. We discovered and developed the first medicines to treat the underlying cause of cystic fibrosis (CF), a rare, life-threatening genetic disease. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases. Founded in 1989 in Cambridge, Massachusetts, our corporate headquarters is now located in Boston’s Innovation District, and our international headquarters is in London, United Kingdom. We currently employ approximately 3,500 people in the United States, Europe, Canada, Australia and Latin America with nearly two-thirds of our staff dedicated to research and development. Vertex is consistently recognized as one of the industry’s top places to work by Science Magazine, The Boston Globe, Boston Business Journal and the San Diego Business Journal. Our research and medicines have also received esteemed recognitions, including the Robert J. Beall Therapeutics Development Award, the French Prix Galien and the British Pharmacological Society awards.