Project Manager Clinical Operations (f / m / x)

ZEISS Group; Berlin; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A leading company in the medical device industry is seeking a Clinical Study Manager to oversee clinical studies, ensuring compliance with regulatory standards and effective project management. The ideal candidate will have a strong background in clinical affairs and excellent communication skills. Responsibilities include developing study protocols, coordinating with study sites, and managing data analysis and reporting. This role offers the opportunity to work in an international environment and contribute to innovative clinical research.

Qualifikationen

• Extensive experience in clinical affairs or research project management.
• Deep knowledge of regulatory requirements for clinical studies.

Aufgaben

• Develop study protocols in collaboration with Clinical Affairs Manager.
• Organize and manage clinical studies, ensuring timelines and budgets are met.
• Prepare and submit applications for clinical study approvals.

Kenntnisse

Project Management

Analytical Skills

Communication

Ausbildung

Minimum four-year college/university degree in optometry, medicine, medical technology, or natural sciences

Jobbeschreibung

Development of study protocols: Collaborate with the Clinical Affairs Manager and Clinical Partners to develop study protocols.

Test methods: Define and ensure availability of test methods according to current standards and guidelines, along with necessary devices.

Study site coordination: Select and coordinate with national and international study sites and service providers; establish long-term clinical partnerships globally.

Contract management: Draft and negotiate contracts with clinical partners in collaboration with the legal department, including investigator fee negotiations.

Regulatory submissions: Prepare and submit applications for clinical study approvals to authorities and ethics committees.

Study organization and execution: Organize and manage clinical studies, coordinate all involved parties, ensure timelines, milestones, and budgets are met, and report progress to management with presentations on results.

Risk management: Identify, assess, and address risks and challenges, implementing preventive and corrective measures, and monitor their effectiveness.

Document management: Ensure the completeness and quality of essential study documents and maintain proper archiving.

Data analysis and reporting: Manage statistical analysis plans, analyze clinical data, prepare study reports, contribute to or review scientific publications, and develop treatment recommendations and indication statements with the CA manager.

Regulatory review: Monitor and evaluate new regulations, guidelines, and standards for clinical studies, and update processes accordingly.

Your Profile

• Minimum four-year college/university degree in optometry, medicine, medical technology, or natural sciences.
• Extensive experience in clinical affairs or research project management within the medical device or pharmaceutical industry, or with contract research organizations.
• Deep knowledge of regulatory requirements for clinical studies, including ICH-GCP, ISO 14155, MDR, MPDG, MDCG, MEDDEV, IMDRF guidelines, and successful experience in planning and conducting clinical studies.
• Proficiency in biostatistics, data management, and regulatory compliance for CE, FDA, NMPA, Health Canada, etc.
• Proven project management skills working with external service providers or vendors, such as CROs.
• Strong analytical, creative, and intuitive skills.
• Excellent communication and organizational skills suitable for an international environment.
• Fluent in English, both oral and written.