Project Manager - Phase I - Germany

Overview

Project Manager for Phase I clinical research studies for a single sponsor partnership (Germany).

What you'll do

• Manage interdisciplinary clinical research studies and ensure compliance with GCP, relevant SOPs, and regulatory requirements.
• Serve as the primary liaison between the company and the customer to support timely study launch, conduct, and closeout.
• Lead the project team to manage quality, timelines, and budget.
• Coordinate study conduct partner activities and deliverables and proactively identify and manage issues.
• Ensure TMF quality and completeness and maintain study information on multiple databases and systems.
• Support inspection readiness and oversee project plan development, implementation, reporting, and risk mitigation.

What you'll need

• Have a Bachelor’s degree (or equivalent) level qualification in life sciences, Medicine, Pharmacy, Nursing, or an equivalent combination.
• Bring previous project management experience in Clinical Research.
• Have Phase I clinical research experience (must).
• Possess strong knowledge of Good Clinical Practice (GCP)/ICH guidelines and applicable regulatory requirements.
• Demonstrate strong organizational skills and the ability to manage time and work independently.
• Be able to embrace new technologies.
• Travel as necessary (approximately 25%).

Details

• Location: DEU-Remote.