Similar Jobs
See allSr. Clinical Trial Manager (Cardiac Catheter Products)
Pulse Biosciences
US
Clinical Trial Management
Medical Device
Regulatory Compliance
Clinical Research Associate I/Clinical Research Associate II
Precision for Medicine
France
Clinical Research
Site Management
Oncology
Temporary Clinical Research Associate
WHOOP
US
Clinical Research
Monitoring
Attention To Detail
Field CRA III (Field Clinical Research Associate III)
Penumbra
US
Clinical Research
Site Management
Regulatory Compliance
Director, Site Start up
Precision for Medicine
Europe
Clinical Research
People Management
GCP/ICH
Role Overview:
- The Senior CRA will play a key role in executing global pivotal and European trials ensuring quality and compliance.
- This role combines CRO oversight, site activation, clinical monitoring, and auditing responsibilities.
Key Responsibilities:
- Oversee CRO and vendor activities while directly contributing to study start-up and conduct.
- Conduct site initiation and monitoring visits, train personnel, and prepare visit reports.
- Verify data accuracy, source documentation, and regulatory files, ensuring compliance with protocols.
Desired Qualifications:
- Bachelor's degree in a scientific field with 5+ years of clinical site management experience.
- Strong background in medical devices, especially Class III cardiovascular devices.
- Proficiency in GCP, FDA, ISO14155, and EDC platforms.
Anteris Technologies
Anteris Technologies is a global structural heart company dedicated to revolutionizing cardiac care through biomimetic TAVR valves. The company has a growing and inclusive team with offices in the US, Switzerland, and Australia.