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- Aufgaben: Monitor clinical sites and ensure adherence to study protocols in medical device trials.
- Arbeitgeber: Join Edwards Lifesciences, a global leader in patient-focused innovations for heart disease.
- Mitarbeitervorteile: Enjoy flexible hours, remote work, wellness programs, and competitive compensation.
- Warum dieser Job: Make a real impact on patient outcomes while working in a dynamic, inclusive environment.
- Gewünschte Qualifikationen: Bachelor's degree and relevant clinical experience required; fluency in German and English essential.
- Andere Informationen: Regular travel within Germany and some international travel is expected.
Das voraussichtliche Gehalt liegt zwischen 48000 - 84000 € pro Jahr.
Overview
Innovation starts from the heart. Edwards Lifesciences is the global leader of patient-focused innovations for structural heart disease and critical care monitoring. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs.
The Clinical Affairs team is looking for an experienced Clinical Research Associate or Senior CRA (depending on experience), to join our team in Germany.
This role will mainly be focused on sites in the western parts of Germany. Suitable locations include Frankfurt, Dusseldorf, Cologne, Bonn, Mainz, Mannheim, and surrounding areas.
This role will be responsible for site monitoring activities to ensure the overall integrity of study implementation and adherence to study protocol at assigned clinical sites. This role will involve working on medical device trials in Cardiology.
How you will make an impact:
- Conduct Clinical Monitoring activities at sites across Germany
- Serve as key contact to assigned clinical sites throughout the study process
- Be accountable for achieving and reporting on agreed clinical milestones
- Support the study team in interactions with Ethics Committees and Competent Authorities
- Participate actively in project team meetings, as required
- Collaborate closely with internal stakeholders to ensure proper project conduct
- Assist in providing site and Edwards personnel training, including preparation/maintenance of study documents, completion of forms, and understanding of examinations/assessments required
- Report site enrollment progress including device accountability and protocol deviations
- Collect completed Case Report Forms (CRF) and supporting documentation
- Process adverse events
- Document procedural case observations for insights into investigating post-procedural events
- Review data, safety reporting, and complaint handling
- Identify and report adverse events and device-related complications in accordance with regulatory and internal requirements
- Develop new improved processes and perform implementation
- Ensure audit readiness for internal, external, and site audits
- Other incidental duties as assigned by management
What you will need:
- Bachelor\’s Degree in a related field, and/or proven record of strong relevant experience
- Previous related medical device and/or clinical experience required
- Previous clinical trial site monitoring experience in Germany within a Medical Device or Pharmaceutical setting
- Experience of different types of monitoring visits and in different study stages
- Quality assurance and regulatory compliance in a clinical research setting
- Driving licence required
- Fluency in both German and English is essential
What else we look for:
- Excellent communication and organizational skills
- Proven expertise in MS Office Suite and ability to operate general office machinery
- Good written and verbal communication skills, presentation, and interpersonal relationship skills including negotiating and relationship management skills
- Good problem-solving and critical thinking skills
- Adherence to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and taking adequate control measures in preventing injuries to themselves and others
- Cardiology and/or medical device study experience desirable
- Driving licence required
This role will require regular travel within Germany (and some international travel).
What is it like to work at Edwards Lifesciences in Germany?
As a global leader in patient-focused medical innovations, we offer rewarding opportunities and exciting challenges in a truly international, dynamic, and friendly work environment.
We are committed to fostering a diverse and inclusive work environment where all employees can grow, personally and professionally. To achieve this, we offer on-the-job development, training opportunities, and the support and guidance provided by dedicated employee groups (the Edwards Network of Women, Edwards Foundation charity team, sustainability activities, and others).
Edwards Lifesciences in Germany also offers the following benefits:
- Competitive Compensation and Benefits package
- Flexible working hours, remote working
- Pension plan
- Insurance Meal Benefits
- Service Awards
- Leave Benefits
- Transportation Benefits
- Employee Stock Purchase Programme
- Employee Assistance Programme
- Comprehensive Wellness Programme including onsite gym, yoga classes, massage, preventive health checks, healthy lifestyle webinars, educational events, charity activities, and much more.
Benefits are regulated by an internal policy which contains the full details regarding the entitlement and conditions for the benefits. Benefits policy and components may vary by location. #J-18808-Ljbffr
Clinical Research Associate / Senior CRA Arbeitgeber: Clinical Research Training Academy
Kontaktperson:
Clinical Research Training Academy HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Clinical Research Associate / Senior CRA
✨Tip Number 1
Familiarize yourself with the specific medical device trials in Cardiology that Edwards Lifesciences is involved in. Understanding the nuances of these trials will not only help you during interviews but also demonstrate your genuine interest in the role.
✨Tip Number 2
Network with current or former Clinical Research Associates at Edwards or similar companies. They can provide valuable insights into the company culture and expectations, which can be a great advantage during your application process.
✨Tip Number 3
Brush up on your knowledge of regulatory compliance and quality assurance in clinical research settings. Being well-versed in these areas will show that you are prepared to handle the responsibilities of the role effectively.
✨Tip Number 4
Prepare for potential travel requirements by ensuring you have a valid driving license and are comfortable with regular travel within Germany. Highlighting your flexibility and readiness for travel can set you apart from other candidates.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Clinical Research Associate / Senior CRA
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure to thoroughly read the job description for the Clinical Research Associate / Senior CRA position. Understand the key responsibilities and required qualifications, especially the importance of site monitoring activities and experience in medical device trials.
Tailor Your CV: Customize your CV to highlight relevant experience in clinical trial site monitoring, particularly in the medical device or pharmaceutical setting. Emphasize your fluency in both German and English, as well as any specific skills related to cardiology.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for patient-focused innovations and your commitment to improving patient outcomes. Mention specific experiences that align with the responsibilities outlined in the job description, such as interactions with Ethics Committees or managing adverse events.
Highlight Soft Skills: In your application, emphasize your excellent communication and organizational skills, as well as your problem-solving abilities. These are crucial for collaborating with internal stakeholders and ensuring compliance with regulatory requirements.
Wie du dich auf ein Vorstellungsgespräch bei Clinical Research Training Academy vorbereitest
✨Understand the Role and Responsibilities
Make sure you have a clear understanding of the Clinical Research Associate role, especially the specific responsibilities related to site monitoring and compliance with study protocols. Familiarize yourself with the medical device trials in Cardiology, as this will be crucial during your interview.
✨Showcase Your Experience
Prepare to discuss your previous clinical trial site monitoring experience in Germany. Highlight any relevant medical device or pharmaceutical experience, and be ready to provide examples of how you've successfully managed site interactions and adhered to regulatory requirements.
✨Demonstrate Communication Skills
Since excellent communication is key for this role, practice articulating your thoughts clearly and confidently. Be prepared to discuss how you've effectively communicated with clinical sites, ethics committees, and internal stakeholders in past roles.
✨Prepare for Behavioral Questions
Expect questions that assess your problem-solving and critical thinking skills. Think of specific situations where you had to navigate challenges in clinical research, and be ready to explain your thought process and the outcomes of your actions.
