About this job

Your tasks

• Management of the entire clinical trials for Class III medical devices – from feasibility assessment to study completion
• Development, maintenance and monitoring of clinical project plans, schedules, budgets and risk management strategies
• Ensuring that all clinical trials are conducted in accordance with GCP (ISO 14155), EU MDR and applicable local regulatory requirements.
• Monitoring of security alerts, management of protocol deviations, and ensuring inspection readiness
• Coordination and collaboration with cross-functional teams, including data management, Clinical Research Associates (CRAs) and other relevant stakeholders.
• Management of contract research organizations (CROs), imaging service providers and other external service providers, including defining the scope of services, monitoring performance and ensuring milestones and results.
• Monitoring of overall study progress, patient recruitment, data quality, and the achievement of key milestones.
• Identification, assessment, and proactive minimization of study-related risks and problems; escalation of critical issues as needed.
• Regular written and oral project reports to management, as well as ensuring effective communication within the study team.
• Ensuring compliance with company-internal standard operating procedures (SOPs) and the correct use of templates, tools and forms.
• Participation in continuous improvement initiatives, including the development of SOPs and the implementation of best practices in the clinical setting.
• Support with the onboarding of new employees as well as – if required – guidance and mentoring of junior project managers and team members.

Your profile

• Bachelor's degree in life sciences, engineering, nursing or a related field; Master's degree preferred
• 7-10+ years of experience in clinical research, including clinical project management
• Proven experience in the simultaneous management of multiple global and complex clinical projects
• Experience in collaborating with contract research organizations (CROs) and external service providers
• A solid background in the clinical development of implantable or other high-risk (Class III) medical devices is advantageous.
• In-depth knowledge of the clinical requirements of the EU MDR and ISO 14155
• Strong organizational, prioritization, and problem-solving skills
• Confident in dealing with fast-paced, dynamic and matrix-organized companies
• Willingness and flexibility to work across different time zones in a global environment
• Willingness to travel of up to 20%

We offer

• Working in an international and dynamic team where collaboration and a hands-on mentality characterize the daily work routine.
• A flexible working environment with a focus on a healthy work-life balance – e.g., working on-site in our office in Bochum, hybrid or remote work possible.
• A comprehensive onboarding program that helps you get up to speed quickly and start successfully.
• Development opportunities within the team and the chance to take on new responsibilities
• A fair and motivating compensation system that values ​​your contribution
• Attractive additional benefits such as company pension schemes (bAV) and capital-forming benefits (VWL)
• Regular company and team events to celebrate successes together.
• JobRad as a sustainable alternative for commuting and leisure
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