Clinical Trials Manager Director

4 giorni fa

Roma, Lazio, Italia Vertex Pharmaceuticals A tempo pieno

Job Overview

Vertex Pharmaceuticals is seeking an experienced Clinical Trials Manager Director to lead global or regional-based activities on complex clinical trials. The ideal candidate will have a strong track record in project management, cross-functional study operations, and vendor management.

About the Role

This key position is accountable for execution of assigned clinical trial(s) at the global or regional level. The successful candidate will be responsible for coordinating internal and external clinical trial management activities, developing operational strategies, and creating detailed study timelines.

Main Responsibilities

  • Execute assigned clinical trial(s) at the global or regional level, according to agreed operational strategy.
  • Coordinate 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.
  • Develop operational strategies and initial timelines with minimal support.
  • Create detailed study timelines with minimal support; monitor progress of timeline with cross-functional Study Team input.
  • Drive study level operational strategy, oversee development and execution of study operational plan(s).
  • Author study documentation and patient recruitment materials.
  • Drive cross-functional vendor identification and set up; ensure appropriate ongoing oversight, including invoicing.
  • Responsible for global clinical trial budget for assigned trial(s) and proactively identifies and manages any anticipated cost overruns.

Key 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.
  • 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.
  • Excellent attention to detail.
  • Ability to work successfully under pressure with tight timelines.

Benefits

As a Clinical Trials Manager Director at Vertex Pharmaceuticals, you will receive a competitive salary of $140,000 - $170,000 per year, depending on experience. Additionally, you will enjoy a comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, and generous paid time off.

Requirements and Qualifications

The ideal candidate will have a Bachelor's degree in a life sciences discipline or relevant discipline, with extensive relevant work experience in the biopharmaceutical industry. Proficiency in Microsoft Office applications, including Outlook, Excel, Word, and PowerPoint, is required.

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