The Clinical Affairs Manager will play a pivotal role in driving the clinical trial activities for our innovative medical devices, both in the United States and internationally. If you are an experienced Clinical Affairs professional who thrives in a fast-paced environment and is passionate about advancing medical device technology through effective clinical research, we encourage you to apply.
General Description and Duties:
The tasks listed below are representative of the knowledge, skill, and/or ability required to perform this job effectively.
- Leads study execution in accordance with the study protocol, Instructions for Use (IFU), US and OUS standards and guidelines, Good Clinical Practices (GCP), and Standard Operating Procedures (SOPs), as applicable
- Management of sites and studies for various clinical projects
- Defines, tracks, and reports metrics (such as schedules, milestones, critical path, and other key deliverables)
- Manages the recruitment, training and development of clinical personnel for the department
- Leads cross-functional collaboration with other departments (such as Medical Education, Engineering, Operations, Quality, Global Marketing, Business Development, Finance, and Executive Management Team)
- Contributes and manages the development of study protocols, Informed Consent Form (ICF), Case Report Forms (CRFs), and any additional study documents for trial conduct (site qualification, initiation, enrollment, monitoring, follow up, and closeout)
- Manages consultant monitors or Clinical Research Organizations (CROs); develops tools for effective communication and efficient processes as part of Sponsor oversight of clinical vendors
- Coordinates and manages multiple projects to meet project timelines/milestones
- Develops departmental or company procedures and/or processes for continuous improvement
- Maintains study oversight and ensures clinical site compliance with the study protocol, standard operating procedures (SOPs) and the applicable federal, state and local regulatory requirements
- Develops action plans with other project leaders and will be responsible for cross-functional collaboration including presenting on behalf of Clinical leadership team, as needed
Projects and Other Duties:
- Perform other duties as assigned by manager.
- Knowledge of medical device regulatory requirements (such as applicable CFRs to medical devices and ICH-E6 GCP and clinical affairs documentation (i.e., adverse events)) is required
- Strong interpersonal skills (areas of mentoring and strategic clinical trial planning) and excellent verbal and written skills are required.
- Travel may be frequent and may involve international trips.
- Bachelor's degree or equivalent experience
- Minimum of 7 years of clinical operations experience in industry and medical device trials is required.
- Previous experience managing teams/people is preferred.
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 $130,000 to $145,000 (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.