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.
To enlarge our Clinical Programs EMEA team we are looking as soon as possible for a
Senior Clinical Project Manager (m/w/d), full-time
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* 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 internal 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
* 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
* Minimum of 5 years of hands-on experience in clinical project management
* Proven experience managing global and/or multi-center clinical studies
* 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
* Familiarity with FDA clinical and regulatory requirements is a strong plus
* Experience working in highly regulated clinical environments with a strong focus on compliance and quality
* Strong leadership, communication, and stakeholder management capabilities
* Excellent organizational, prioritization, and problem-solving skills
* Proven ability to manage multiple complex clinical projects simultaneously
* Comfortable working in fast-paced, dynamic, and matrix-driven organizations
* Proactive, resilient, and adaptable with a solution-oriented mindset
* Ability to effectively xwminpx collaborate across functions and cultures
* Experience supporting or contributing to organizational or cultural change initiatives is an advantage
* Willingness and flexibility to work across multiple time zones in a global organization
* Ability to travel up to 20% as required
* 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