Clinical Monitor / CRA

• Munich ,  Germany
• Direct Hire
• Flexible, depending on experience (contract and permanent options)

Description

Are you an experienced Clinical Research Associate (CRA) with a passion for driving innovative medical advancements?

Do you want to play a key role in bringing life-saving treatments to patients?

Join our client’s team and contribute to cutting-edge clinical research in the medical device field!

Key Responsibilities:

• Oversee clinical project management and day-to-day operations across all study phases, from start-up to close-out.
• Develop, write, and maintain essential clinical study documentation.
• Support the submission of study-specific documents to regulatory authorities, including ethics committees and competent authorities.
• Ensure compliance with clinical study protocols, ISO-14155, ICH-GCP, MDR, and other relevant regulations.
• Maintain and manage Trial Master File (TMF), tracking essential study documents accurately.
• Serve as the primary liaison for study sites, ensuring timely resolution of queries and protocol adherence.
• Support clinical data collection, review, and cleaning activities to ensure high data quality.
• Conduct co-monitoring and monitoring visits, along with sponsor-initiated site visits.
• Coordinate meetings, teleconferences, and study-related updates with Clinical Affairs leadership.
• Collaborate cross-functionally to ensure the smooth execution of clinical studies.

Requirements:

• Bachelor’s degree in Life Sciences, Nursing, or a related field.
• 2+ years of experience as a CRA or CPM in the medical device industry or a Contract Research Organization (CRO).
• Strong knowledge of ISO-14155, ICH-GCP, MDR, and regulatory guidelines.
• Experience with electronic data capture and tracking systems.
• Monitoring experience is a plus.
• Excellent organizational, teamwork, and communication skills.
• Proficiency in Microsoft Office.
• Fluency in English is required; German language skills are a plus.

What’s in it for you?

• A unique opportunity to join a growing, innovative medical device company.
• A dynamic role where you’ll work closely with clinical management and make a real impact.
• Career growth in a collaborative, fast-paced environment dedicated to improving patient care.

If you're ready to take the next step in your career and contribute to life-changing medical advancements, apply now and/or contact Hollie Dear at Adaptive Life Science for more information!