The Director or Clinical Operations is responsible for the management and oversight of clinical operations. The ideal candidate will provide direct support and supervision to clinical staff. Supports all clinical programs, will assist with planning and executing clinical trials while ensuring compliance with applicable regulations and standards.
General Description and Duties:
To perform this job successfully, an individual must be able to perform each essential task satisfactorily. The tasks listed below are representative of the knowledge, skill, and/or ability required to perform this job effectively.
- Responsible for executing clinical strategies and ensure clinical trials are conducted efficiently to agreed corporate timelines and follow local and global requirements
- Work cross-functionally with other departments and functions to implement clinical trial protocols
- Participate and assist in the design and preparation of protocols and case report forms
- Generate clinical SOPs, policies, charters and plans according to U.S. and international guidelines
- Evaluate potential clinical contract research organizations (CROs) and sites according to established criteria of acceptability
- Responsible for procurement of budgets, contracts, regulatory documents and other administrative documents as related to clinical research functions
- Develop and implement site and user training and supporting materials to ensure safe and effective use of products in accordance with study protocol, product parameters and regulatory requirements
- Oversee CROs, clinical vendors and consultants
- Manage activities of clinical operations staff
- Prepare clinical documents for regulatory submissions
- Attend scientific and external training meetings as needed
- Mentor and may supervise clinical operations staff, including CRAs and CTAs
Projects and Other Duties:
- Knowledge of current and new healthcare industry trends, technologies, competitors, and place in the market
- Working knowledge of clinical research
- Demonstrates a continuous desire to understand, learn and implement industry best practice and trends
- Strong leadership and written and verbal communication skills
- High-performer and results driven
- BA or BS degree in a health-related field
- Master's degree preferred
- Minimum 5 years healthcare and medical device experience
Aligning our overall business objectives with performance and merit based pay, Axonics offers competitive salaries, performance-based incentives, and Employer paid benefits programs to address the diverse individual needs of our employees and their families. At Axonics, our employees come first!
For California, the base pay range for this position is $200,000 to $220,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).
Axonics is an Equal Opportunity Employer, included protected Veterans and individuals with disabilities.