Clinical Project Manager

Clinical Affairs           ·            Irvine, CA          ·         Full time

Job Title: Clinical Project Manager

FLSA: Salaried Exempt

 Department: Clinical Affairs 

Reports To: Director, Clinical Affairs

To apply, e-mail your resume to careers@axonics.com

Job Responsibilities:

The Clinical Project 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
• Tracks and reports metrics.
• Contributes to 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).
• Coordinates and manages projects to meet timelines and milestones
• 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.
• Reviews monitoring reports and assists with closing out Site and Sponsor action items.
• Assists with development and User Acceptance Testing (UAT) of clinical databases.
• Manages and oversees the Trial Master File (eTMF) and Clinical Trial Management Systems (CTMS).
• Works with Accounts Payable in generating invoices for site grant payments.
• Assists with Ethics Committee or Institutional Review Board submissions.

Projects and Other Duties:

• Perform other duties as assigned by manager.

Position Qualifications

• 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.

Minimum Education:

• Bachelor’s degree or equivalent experience (7 years of hands-on clinical research).

Minimum Experience:

• Minimum of 7 years of clinical operations experience in industry and medical device trials is required.
• Previous experience managing teams/people is preferred.

Salary:

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 $120,000 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.

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