Clinical Project Manager
IQVIA
Google Cloud Platform
Clinical Operations Manager
Sonova Group
full-time
Posted on:
Location: California • 🇺🇸 United States
Visit company websiteSalary
💰 $94,400 - $141,600 per year
Job Level
Mid-LevelSenior
About the role
- Ability to effectively plan, lead, and close feasibility and pivotal trials
- Expert knowledge of regulatory requirements for clinical trials
- Complete site selection and define recruitment strategies, including risk analysis and mitigation
- Manage study budgets and timelines
- Complete vendor selection and management
- Oversight of study staff work allocation and site compliance
- Manage the development of standardized work instructions and operating procedures
- Provide oversight for Trial Master File development, maintenance, and reconciliation
- Responsible for reviewing study documents, (e.g. protocols, clinical study reports, Manual of Operations, reference guides).
- Collaborate with data management and product development functions
- Other duties as assigned.
- Travelling Requirement: Up to 30% travel to study centers, professional conferences, and corporate events.
Requirements
- 5 years of experience with clinical trials
- Bachelor’s degree in a medically related discipline
- Experience with active implantable or Class 3 medical devices
- Training in clinical trial management
- Training in electronic data management
- Experience with regulatory requirements for clinical trials (FDA, ISO)
- IT Skills: Expertise with standard MS Office Software
