Project Manager – Clinical Trial Lead

This is a fully remote position, open to applicants in Germany.

📋 Description

• Provides direction and management to ensure consistent and high-quality execution of global clinical trials.

• Oversees interdisciplinary clinical research studies as a project manager, ensuring adherence to GCP, relevant SOPs, and regulatory standards.

• Serves as the main point of contact between the Company and the Customer to guarantee timely study initiation, execution, and closure in alignment with contractual agreements.

• Guides the project team to maintain quality, adhere to timelines, and manage budgets effectively.

• Responsible for the financial outcomes of each project.

• Coordinates the activities and deliverables of all study conduct partners while proactively identifying and addressing issues.

• Ensures compliance with GCP, relevant SOPs, and regulatory requirements throughout the studies.

• Holds accountability for all project deliverables for each assigned project.

• Responsible for the quality and completeness of the Trial Master File (TMF) for designated projects.

• Ensures the accurate maintenance of study information across various databases and systems.

• Oversees the study management components related to inspection readiness for all study conduct aspects.

• Manages the development and implementation of project plans.

• Plans, organizes, and presents at both internal and external meetings.

• Prepares project management reports for clients and management teams.

• Develops contingency plans and risk mitigation strategies to ensure successful achievement of study objectives.

• Cultivates strong relationships with existing clients to foster new and/or additional business opportunities in the future.

• May take part in bid defense meetings as a potential project manager.

• May have responsibilities in managing other project management team members and clinical monitoring staff.

⛳️ Requirements

• Bachelor's Degree (or equivalent) in life sciences, Medicine, Pharmacy, Nursing, or a related combination of education and experience.

• Prior experience in a clinical research organization (CRO) and relevant therapeutic areas is preferred.

• Strong understanding of Good Clinical Practice/ICH guidelines and other applicable regulatory standards.

• Previous experience in leading global clinical trials.

• Excellent organizational skills.

• Significant global experience.

• Strong capability to manage time effectively and work independently.

• Direct expertise in therapeutic areas.

• Willingness to embrace new technologies.

• Outstanding communication, presentation, and interpersonal skills, both written and verbal.

• Ability to travel as needed (approximately 25%).

🏝️ Benefits

• We are dedicated to the development of our personnel through career advancement and progression; supportive and engaged line management; technical and therapeutic training; peer recognition; and a comprehensive rewards program.

• We prioritize creating an inclusive culture where you can truly be yourself.

• Driven to Deliver – this embodies the commitment of our colleagues to come in each day and create solutions that can significantly impact someone's life.

• Continuously building the company that we all aspire to work for, and that our customers want to collaborate with.