Jobbeschreibung
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
Lead Clinical Research Associate (m/w/d), full-time
- Leading a team of assigned CRAs across different countries, you coordinate and guide their work to ensure study milestones are delivered efficiently, accurately, and on time
- Actively participating in the creation of clinical monitoring plans, monitoring tools, visit report annotations, and CRA training materials, you also promote the ongoing enhancement of monitoring SOPs and templates to make monitoring activities more efficient and intelligent
- With your experience and expertise, you train and mentor CRAs on study- and monitoring specific requirements, maintaining full training compliance and building a culture of excellence and accountability
- Conducting co-monitoring visits internationally or, if necessary, on-site visits in the DACH region, including SQV, SIVs, IMVs or COVs, to guarantee consistency, quality, and strong relationships with our clinical sites throughout
- Assisting each study in getting off to a good start and maintaining timelines by supervising regional start-up and feasibility activities
- Working closely with clinical project managers, study coordinators, and data managers, you share insights, overcome challenges, and continuously drive best practices forward
- You also ensure that CRAs always keep their sites inspection-ready, including maintaining a complete and compliant Investigator Site File and Trial Master File (TMF) for potential health authority inspections
- A bachelor's degree (or equivalent), ideally in life sciences, medicine, or a related field
- At least five years of experience in clinical research within an international environment, including a minimum of three years in clinical site monitoring
- Knowledge of relevant regulations such as ICH, GCP, ISO 14155 and GDPR
- A passion for continuous learning, you enjoy developing your skills and staying up to date through regular training or on-the-job experience
- Excellent communication skills in both writing and speaking, combined with strong interpersonal abilities and a talent for organization
- A proactive mindset, you are detail- and solution-oriented as well as reliable
- Willingness to travel within the DACH region and across Europe (up to 35–45% travel time)
- Fluent in German and English; knowledge of any additional language is welcome
- Previous experience in line management of CRAs would be a plus
- 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