Clinical Research Associate (CRA) Europe (m/f/d)

Optimed Group; Deutschland; Hybrid; USD 58,568 - 81,995; Full time

Job summary

optimed Medizinische Instrumente GmbH is seeking an experienced Clinical Research Associate to oversee post-market clinical studies for neurovascular and peripheral vascular interventional medical devices. This role will ensure compliance with ICH-GCP and EU Medical Device Regulation while managing multiple trial sites in Europe, particularly Germany.

The ideal candidate will have a Bachelor's degree in a relating field, at least 3 years of monitoring experience, and fluency in German and English. The position requires strong organizational skills and a willingness to travel extensively.

Qualifications

• Minimum of 3 years of independent monitoring experience in the medical device or pharmaceutical industry.
• Solid knowledge of EU Medical Device Regulation (MDR), ICH-GCP, ISO 14155.
• Ability to manage multiple sites independently and willingness to travel extensively.

Responsibilities

• Manage site activities for assigned clinical sites in Europe.
• Ensure study conduct complies with approved protocol and GCP.
• Perform source data verification and manage investigational device accountability.

Skills

Fluent in German and English

Strong organizational skills

Problem-solving skills

Team collaboration

Education

Bachelor's degree or higher in Medicine, Pharmacy, Life Sciences

Tools

Electronic Data Capture (EDC) systems

Clinical trial management tools

Job description

We are seeking an experienced Clinical Research Associate (CRA) to support post‑market clinical studies for neurovascular and peripheral vascular interventional medical devices across Europe. The role focuses on ensuring clinical trial compliance with ICH‑GCP, ISO 14155, EU Medical Device Regulation (MDR), and local regulatory requirements. The ideal candidate will have a strong background in medical device clinical monitoring within Europe, particularly in Germany, and will be capable of independently managing multiple trial sites.

Your Qualifications & Experience:

Essential Requirements:

• Bachelor's degree or higher in Medicine, Pharmacy, Life Sciences, or a related discipline.
• Minimum of 3 years of independent monitoring experience in the medical device or pharmaceutical industry, preferably with exposure to neurovascular, peripheral vascular, cardiology, or interventional device studies.
• Solid knowledge of EU Medical Device Regulation (MDR), ICH‑GCP, ISO 14155, and local regulatory and ethics submission processes.
• Ability to manage multiple sites independently and willing to travel extensively.
• Fluent in both German and English (written and spoken), with the ability to communicate complex medical information clearly.
• Strong organizational, problem‑solving, and team collaboration skills.

Preferred Qualifications:

• Hands‑on experience in post‑market clinical studies (PMS/PMCF) or regulatory‑focused clinical trials.
• Familiarity with Electronic Data Capture (EDC) systems and clinical trial management tools.

Your contribution to our mutual success:

• Manage site activities for assigned clinical sites in Europe (with emphasis on Germany), including site feasibility, initiation, monitoring, and close‑out visits.
• Ensure study conduct complies with the approved protocol, Good Clinical Practice (GCP), ISO 14155, and relevant national regulations.
• Perform source data verification (SDV), review case report forms (CRFs), manage investigational device accountability, and track safety reporting.
• Establish and maintain effective communication with Principal Investigators (PIs), site staff, and clinical research coordinators (CRCs) to ensure study progress and data quality.
• Prepare monitoring visit reports, track study progress, identify risks and issues, and contribute to resolution plans.
• Support essential document preparation, submission to ethics committees and competent authorities, and contract negotiation processes.
• Collaborate cross‑functionally with Medical Affairs, Data Management, Biostatistics, and Regulatory Affairs teams to achieve study milestones.