Senior Clinical Project Manager (m/w/d), full-time

phenox GmbH; Bochum; Hybrid; EUR 90.000 - 130.000; Vollzeit

Benefits dieser Stelle

Company pension scheme (bAV)

Capital-forming benefits (VWL)

JobRad

Zusammenfassung

phenox GmbH in Bochum seeks an experienced Clinical Project Manager to lead end-to-end management of Class III device studies. You will develop study plans, timelines, budgets, and risk strategies while ensuring GCP and EU MDR compliance.

Coordinate with CROs and cross-functional teams, monitor enrollment and data quality, and provide regular updates to management. Hybrid/remote options available within a global team; travel up to 20% may be required.

Qualifikationen

• Bachelor's degree in Life Sciences, Engineering, Nursing, or related field; master's preferred.
• 7–10+ years in clinical research and clinical project management.
• Experience managing global, complex clinical projects simultaneously.
• Proven CRO/vendor management and external vendor collaboration.
• Strong knowledge of EU MDR, ISO 14155, and high-risk implantable device development.
• Excellent organizational and problem-solving skills; able to work in fast-paced, matrix-driven environments.

Aufgaben

• Lead end-to-end management of Class III medical device clinical studies from feasibility to close-out.
• Develop, maintain, and track study plans, timelines, budgets, and risk strategies.
• Ensure studies comply with GCP (ISO 14155), EU MDR, and local regulatory requirements.
• Oversee safety reporting, protocol deviations, and inspection readiness.
• Coordinate with Data Management, CRAs, and cross-functional stakeholders.
• Manage CROs, imaging vendors, and other third-party providers, including scope and milestones.
• Monitor study progress, enrollment, data quality, and milestones.
• Identify and mitigate study risks and escalate critical topics as needed.
• Provide regular written and verbal updates to line management.

Kenntnisse

Clinical project management

GCP/ISO 14155 knowledge

Cross-functional collaboration

Regulatory compliance

Travel readiness

Ausbildung

Bachelor's degree in Life Sciences/Engineering/Nursing (Master's preferred)

Jobbeschreibung

YOUR JOB DUTIES

• 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; elevate 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.