Project Manager II, Early Development – FSP Model

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

📋 Description

• 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 facilitate timely study initiation, execution, and completion in line with contractual agreements.

• Leads the project team to maintain quality, manage timelines, and oversee budgetary constraints.

• Responsible for the financial outcomes of each assigned project.

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

• Ensures that studies comply with GCP, relevant SOPs, and regulatory requirements.

• Accountable for all deliverables associated with each assigned project.

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

• Manages the upkeep of study information across various databases and systems.

• Oversees study management elements to ensure readiness for inspections related to all phases of study conduct.

• Provides guidance on the creation and execution of project plans.

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

• Prepares project management reports for clients and upper management.

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

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

• May participate in bid defense meetings as a candidate for project manager roles.

• May be required to supervise other project management team members and clinical monitoring staff.

⛳️ Requirements

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

• Preferred experience in clinical research organizations (CRO) and relevant therapeutic areas.

• In-depth understanding of Good Clinical Practice/ICH guidelines and other regulatory requirements.

• Strong organizational skills and experience in Early Phases of clinical research.

• Proven ability to manage time efficiently and work autonomously.

• Direct expertise in therapeutic areas.

• Openness to adopting new technologies.

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

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

🏝️ Benefits

• We are dedicated to the development of our employees through career advancement and growth opportunities.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition and a comprehensive rewards program.

• We are committed to fostering an inclusive culture where you can genuinely be yourself.