Regional Project Lead

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  • Company Jobgether
  • Employment Full-time
  • Location 🇺🇸 United States nationwide
  • Submitted Posted 1 day ago - Updated 8 hours ago

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Regional Project Lead in United States.

In this senior clinical operations role, you will oversee and coordinate cross-country and regional clinical project activities, ensuring smooth execution of studies from planning through closeout. You will act as a key point of contact between project teams, clinical sites, and support functions, driving consistency in processes and ensuring compliance with global regulatory standards such as ICH-GCP. The role combines strategic oversight with hands-on operational leadership, where you will monitor timelines, manage KPIs, and ensure patient enrollment and study milestones are achieved. You will also play a central role in team coordination, training, and performance management across regions. Working in a fast-paced, science-driven environment, you will contribute directly to the successful delivery of clinical trials that support the development of new medicines. This is a high-impact position where leadership, precision, and collaboration are essential.


Accountabilities

In this role, you will lead regional clinical project execution, ensuring operational alignment, regulatory compliance, and timely delivery of study objectives. Your responsibilities will include:

  • Managing and coordinating clinical project teams across designated countries and regions to ensure consistent execution of study activities
  • Ensuring project planning and implementation comply with ICH-GCP, regulatory requirements, and internal study documentation standards
  • Acting as a primary or secondary project management contact for internal teams and support functions
  • Tracking, analyzing, and reporting study progress, KPIs, timelines, and enrollment performance across regions
  • Coordinating site start-up activities, including contractual processes, budgets, regulatory submissions, and ethics approvals
  • Supervising monitoring activities including site selection, initiation, routine visits, and closeout procedures
  • Overseeing investigator communication, training activities, and therapeutic area education for project teams
  • Ensuring proper management of study systems, documentation, CRFs, and query resolution processes
  • Supporting audit and inspection readiness and overseeing resolution of findings
  • Managing communication flow across stakeholders and identifying/mitigating resourcing or performance risks

Requirements

The ideal candidate brings strong clinical research leadership experience combined with operational excellence in trial execution. You will have:

  • Degree in Life Sciences or equivalent combination of education and relevant clinical research experience
  • Significant experience in clinical research, including on-site monitoring and study execution
  • Prior experience as a Study Manager or Clinical Trial Manager, ideally with regional or multi-country oversight responsibilities
  • Oncology clinical trial experience (required) and GI experience (preferred)
  • Strong understanding of ICH-GCP guidelines, clinical trial processes, and regulatory requirements
  • Proficiency in MS Office tools, including MS Project
  • Strong communication, presentation, and stakeholder management skills
  • Ability to lead teams, build relationships, and manage cross-functional collaboration effectively
  • Strong organizational, problem-solving, and leadership capabilities
  • Full professional proficiency in English

Benefits

  • Opportunity to lead regional clinical trials with global impact
  • Hands-on involvement across all stages of clinical study execution
  • Career growth within a rapidly growing, people-focused organization
  • Exposure to complex, full-service clinical research projects
  • Collaborative and mission-driven work environment focused on medical innovation
  • Professional development opportunities in clinical operations leadership
  • Work in a global structure with cross-functional international teams


How Jobgether works:

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

 Why Apply Through Jobgether? 

 

Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.

 

 

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