Lead the end-to-end management of clinical studies for Class III medical devices, from feasibility assessment through study close-out
Develop, maintain, and track clinical project plans, timelines, budgets, and risk management strategies
Ensure all clinical studies are conducted in compliance with GCP (ISO 14155), EU MDR, and applicable local regulatory requirements
Oversee safety reporting activities, management of protocol deviations, and ensure inspection readiness
Coordinate and collaborate with cross-functional teams, including Data Management, Clinical Research Associates (CRAs), and other relevant stakeholders
Manage Contract Research Organizations (CROs), imaging vendors, and other third-party service providers, including scope definition, performance oversight, and delivery of milestones and deliverables
Monitor overall study progress, patient enrollment, data quality, and achievement of key milestones
Identify, assess, and proactively mitigate study-related risks and issues; escalate critical topics as appropriate
Provide regular written and verbal project updates to line management and ensure effective communication within the study team
Ensure compliance with company Standard Operating Procedures (SOPs) and the appropriate use of templates, tools, and forms
Contribute to continuous process improvement initiatives, including SOP development and implementation of best practices in clinical operations
Support the onboarding of new associates and, where required, provide guidance and mentorship to junior project managers and study team members
YOUR PROFILE
Bachelor’s degree in Life Sciences, Engineering, Nursing, or a related discipline; Master’s degree preferred
7–10+ years of experience in clinical research, including clinical project management
Proven experience managing multiple global and complex clinical projects simultaneously
Demonstrated experience working with Contract Research Organizations (CROs) and external vendors
Strong background in clinical development for implantable or other high-risk (Class III) medical devices preferred
In-depth knowledge of EU MDR clinical requirements and ISO 14155
Excellent organizational, prioritization, and problem-solving skills
Comfortable working in fast-paced, dynamic, and matrix-driven organizations
Willingness and flexibility to work across multiple time zones in a global organization
Ability to travel up to 20% as required
WE OFFER
Be part of an international and dynamic team where collaboration and a hands-on mentality drive daily work
A flexible working environment that supports a healthy work-life balance e.g. this role can be on-site in our Bochum office, hybrid or remote
Benefit from a comprehensive onboarding program to help you quickly feel at home and succeed in your role
Grow with us - we offer the possibility to evolve within the team and take on new responsibilities
A fair and motivating remuneration system that values your contribution
Attractive benefits such as a company pension scheme (bAV) and capital-forming benefits (VWL)
Celebrate successes together at regular company and team events
JobRad as a sustainable alternative for your commute to work and in your free time
About us
phenox GmbH is a specialized manufacturer of Class III medical devices for the treatment of neurovascular diseases, which are developed, manufactured and distributed. Our innovative technologies and solutions are used by neuroradiologists worldwide to treat strokes and aneurysms. We offer a growing portfolio of innovative treatment options - including long-established technologies.
