Senior Clinical Project Manager (m/w/d)

Senior Clinical Project Manager (m/f/d) – Medical Devices

Responsibilities:

• Lead and manage both local and international clinical trials, specifically focusing on medical devices.
• Oversee and coordinate internal and cross-functional clinical trial teams, ensuring internal deliverables are met while managing budgets, forecasts, and timelines.
• Contribute to the preparation, review, and approval of key documents, including clinical study protocols, reports, plans, and informed consent forms.
• Regularly provide up-to-date reports on study status using internal information systems and tracking tools.
• Select and qualify clinical trial vendors, develop and implement sponsor and vendor oversight plans, and evaluate key performance indicators.
• Maintain effective communication and manage relationships with stakeholders, ensuring escalation processes are followed when necessary.
• Ensure compliance with internal SOPs and relevant regulatory requirements, while identifying quality risks and implementing corrective actions.
• Support quality audits and collaborate with relevant departments to manage Corrective and Preventive Actions (CAPAs).
• Foster an open, trust-based working environment and drive change to promote continuous improvement.
• Contribute to the enhancement of internal processes, including SOPs, Work Instructions and the implementation of new IT/software initiatives.

Requirements:

• University degree (Bachelor’s) in life sciences, medical healthcare
• At least 4 years of experience managing complex, international clinical trials with medical devices in both pre- and post-market stages.
• Over 8 years of comprehensive experience across various medical indications, study designs, and phases of clinical development for medical devices or medicinal products.
• In-depth knowledge of clinical research practices and regulations (ICH-GCP, ISO 14155, MDR, FDA, EU-CTR, etc.), as well as experience with clinical trial application submissions.
• Strong experience leading interdisciplinary, international teams and providing leadership in a cross-functional environment.
• Team player with demonstrated professional leadership skills.
• Proven ability to develop tools and processes to enhance project efficiency.
• Experience with IVRS and EDC systems.
• Solid understanding of project management methods and tools (e.g., MS Project).

About the Client:

This company offers a great working environment with a global perspective and the opportunity to work in an international team. The flexible hybrid model allows you to work 2 days in the office and 3 days remotely. With an average employee tenure of over 8 years, the company provides long-term stability and growth opportunities. In addition to a competitive salary, employees enjoy attractive benefits such as Wellpass, Jobticket, Jobbike, 39 vacation days, a pension plan, and childcare support.

If you\’re passionate about driving clinical trials forward in the field of medical devices, with a strong emphasis on cross-functional leadership, efficiency, and quality compliance, we encourage you to apply.

Contact details:

E-Mail:

Tel: 089 26 20 09 25

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