project manager in clinical research

Parexel conducts clinical research and manages Phase I and II studies for sponsors in pharmaceutical, biotechnology, and healthcare settings.

• Initiate, plan, manage, and close out Phase I and II projects with all departments of the EPCU Berlin, including external vendors and units;
• Own the sponsor relationship and manage sponsor communications;
• Provide a central study contact on behalf of functional teams and vendors;
• Report and update project progress internally and with sponsors and external vendors;
• Lead regular project team meetings to ensure project objectives are met;
• Control budgets for Phase I and II studies, including vendor service inquiries, budget and contract negotiations, forecasting, tracking, and invoicing;
• Ensure compliance with SOPs, contract terms, and system requirements;
• Set up project-specific training in the Parexel system and oversee training;
• Deliver projects and programs on time, within budget, and to the highest quality in compliance with ICH, GCP, and applicable regulations;
• Ensure operational excellence and successful execution of clinical operations and logistical strategies.

• Proven project management experience in clinical research;
• Experience as a functional team leader in clinical, data management, or logistics functions, or proven experience coordinating clinical trials;
• Presentation and speaking skills in English and German;
• Organizational skills and the ability to work under pressure and multitask;
• In-depth knowledge of guidelines, ICH-GCP, and AMG;
• Solid computer and internet skills, including MS Office, Excel, Word, PowerPoint, and Project;
• Bachelor's degree in a science-related field or substantial related work experience as a clinical research project manager;
• Nice to have: Scientific, medical, or pharmacology background.

• Office-based position in Berlin.