Clinical Trial Project Manager

Our Mandant, an innovative biotech company in the clinical Phase 2 stage, is seeking a Clinical Trial Project Manager to oversee the execution of international clinical trials in the field of neurodegenerative and ophthalmologic diseases.

Your Responsibilities

• Drafting and reviewing clinical trial documents, including study protocols, patient information, investigator brochures, study plans, manuals, and reports
• End-to-end execution of clinical trials, including comprehensive monitoring activities from study start-up through close-out
• Development of deviation plans; defining and assessing protocol deviations at patient, site, and study level, and recommending follow-up actions
• Providing clinical expertise and conducting risk/benefit assessments
• Oversight and management of CROs and other vendors (e.g., labs)
• Managing study budgets, overseeing change orders, and reviewing/approving invoices
• Contributing to the selection of clinical service providers
• Reviewing and tracking study documents for regulatory submissions
• Supporting audits and inspections (GCP), and contributing to CAPA development and implementation
• Reviewing data management documents (e.g., DMP, DVP) and biostatistics documents (e.g., SAP, TFL)
• Coordinating study logistics including medication, samples, materials, and managing the Trial Master File
• Monitoring and analyzing clinical study data
• Preparing and delivering internal and external presentations
• Conducting trainings related to study processes and procedures
• Supporting the development and review of SOPs

Your Qualifications

• Degree in a life science or medical-related field
• Minimum 3 years of experience in conducting and managing clinical studies
• Proven professional experience in the biotechnology industry
• Solid understanding of GCP/GCLP guidelines and regulatory frameworks
• Experience in clinical trial budgeting and vendor selection
• Excellent English verbal and written communication skills - german is a plus

What the Mandant Offers

• Fully remote work setup within Germany
• A role within a fast-moving and globally oriented biotech environment
• Direct communication structures and minimal bureaucracy
• Attractive performance-based bonus scheme

Seniority level

• Associate

Employment type

• Full-time

Job function

• Science, Research, and Project Management

Industries

• Biotechnology Research and Pharmaceutical Manufacturing

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Cologne, North Rhine-Westphalia, Germany