Join this dynamic team dedicated to revolutionizing patient care with innovative, minimally invasive treatment solutions for cardiovascular diseases.
We are seeking a proactive and skilled Clinical Trial Manager / Clinical Project Manager to play a vital role in this expanding medical device company based in Munich, Germany. This is a unique opportunity to work closely with the clinical affairs team and contribute to improving patient outcomes.
In this position, you will oversee clinical project management and day-to-day operations throughout the study lifecycle. Your expertise will ensure that our clinical studies adhere to the highest standards while fostering collaboration across cross-functional teams.
Key Responsibilities
* Oversee clinical project management and day-to-day clinical operations throughout the entire study lifecycle, including start-up, execution, and close-out.
* Maintain in-depth knowledge of protocol, therapeutic area, and indication.
* Contribute to the development and writing of clinical study documentation and processes.
* Ensure study conduct aligns with the clinical study protocol and relevant regulations.
* Serve as the primary point of contact for study sites, ensuring prompt resolution of inquiries to maintain protocol compliance.
* Support timely clinical data collection, review, and cleaning activities to ensure high data quality and resolve any discrepancies.
* Responsible for management of study vendors.
* Maintain accurate and up-to-date study documentation and Trial Master File (TMF), including the collection, administration, and tracking of essential documents.
* Support the submission of study-specific documents to regulatory authorities, including ethics committees and competent authorities.
* Conduct co-monitoring and monitoring visits, as well as other sponsor-initiated visits at study sites if required.
* Monitor study progress and provide regular updates to Clinical Affairs leadership.
* Collaborate with cross-functional teams to ensure seamless execution of clinical studies.
Required Qualifications and Skills
* Bachelor’s degree in Life Sciences, Nursing, or a related field.
* Minimum of 4 years of experience in Clinical Trial Management within the medical device industry or a Contract Research Organization (CRO).
* Demonstrated ability to drive clinical trial activities: experience in all aspects of study start-up and conduct, regulatory obligations, adverse event reporting, etc.
* In-depth working knowledge of ISO-14155, ICH-GCP, MDR, and associated guidelines.
* Ability to work independently and manage multiple priorities.
* Experience with electronic data capture and tracking systems.
* Monitoring experience is advantageous.
* Knowledge of cardiovascular medicine is a plus.
* Strong attention to detail, with excellent organizational and teamwork skills.
* Exceptional communication abilities.
* Proficiency in Microsoft Office.
* Proficiency in English is required; German language skills are an advantage.
How to Apply
If you are ready to take on this exciting opportunity, please submit your resume outlining your qualifications and experience. We look forward to hearing from you!
Rebecca.Stevens@adaptivelifescience.com
Tel: +49 30 16 63 93 35