Project Manager (Clinical Research)

TL;DR

Project Manager (Clinical Research): Managing the setup, execution, and closure of Expanded Access Programs (EAPs) with an accent on electronic trial master files, regulatory compliance, and cross-functional coordination. Focus on mitigating project risks, managing vendor deliverables, and ensuring deliverables are achieved on time and within budget.

Location: Must be based in the US (Remote or Morrisville, North Carolina)

Company

A mission-driven organization dedicated to advancing clinical research and transforming lives through impactful solutions for clients and patients.

What you will do

• Manage project setup, execution, and close-out in accordance with SOPs and policies.
• Oversee day-to-day operations ensuring compliance with contracts, laws, and regulations.
• Develop and maintain comprehensive project plans and timelines using MS Project.
• Serve as the primary point of contact for clients regarding project deliverables and concerns.
• Provide cross-functional oversight for monitoring, site management, data management, and regulatory activities.
• Proactively identify and mitigate project risks while managing budgets and vendor deliverables.

Requirements

• Bachelor's Degree, preferably in a health or science field.
• 3-6 years of experience in project management or clinical research.
• Proficiency in Microsoft Office and general computer literacy.
• Effective verbal and written communication skills.
• Ability to handle confidential information with complete discretion.
• Must be based in the US.

Culture & Benefits

• Dynamic team environment that encourages innovation and collaboration.
• Opportunity to work in a mission-driven organization improving patient outcomes.
• Culture of challenging the team to bring forward ideas that make a real difference.