Clinical Study Manager

Axogen is committed to building and maintaining a strong and gratifying company culture that fosters professional growth. Our hands-on and personal approach makes transitioning to a new job a seamless and enjoyable process. Most benefits are effective on day one!

Axogen is an equal opportunity employer and does not discriminate against applicants on the basis of race color creed religion ancestry age sex marital status national origin disability or veteran status.

Why youll love working atAxogen:

• Friendly openandfunteam culturethat values uniqueperspectives
• Company-wide dedicationto profoundly impacting patients lives
• Comprehensive high-quality benefitspackage effective on date of hire
• Educationalassistanceavailable for all employees
• Matching 401(k)retirementplan
• Paid holidaysincluding floating holidaysto be used at your discretion
• Employee Stock Purchase Plan
• Referral incentive program

Axogen Mission and Business Purpose

Our business purpose is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. We aim to lead the markets we serve by always requiring the solutions we offer patients and caregivers provide an improved benefit-to-risk profile as compared to existing standards of care. To ensure we deliver improved benefit-to-risk solutions we will guide and expect the market and design requirement specifications underlying our engineering business development and clinical research activities objectively target advancements in standards of care.

Job Summary of the Clinical Study Manager

The Clinical Study Manager (CSM) is accountable for the endtoend operational leadership of an Axogensponsored randomized controlled trial (RCT) and other complex prospective clinical studies conducted in highly regulated environments including biologics combination products and medical devices. This role is intended for a highly experienced clinical operations professional who can independently own study execution serve as the operational authority for an assigned trial and act as a role model for CRAs vendors and crossfunctional partners. The CSM is responsible for ensuring exceptional execution quality data integrity and inspection readiness while maintaining the highest standards of ethics and Good Clinical Practice (GCP).

Requirements of the Clinical Study Manager

• Bachelors degree or higher in a scientific medical or engineering discipline (or equivalent experience).
• Minimum 5 years of industrysponsored clinical research experience.
• Demonstrated experience leading complex prospective interventional studies with RCT experience strongly preferred.
• Experience conducting studies in biologics combination products and/or medical devices.
• Proven track record of maintaining high data integrity compliance and inspection readiness.
• Strong working knowledge of ICHGCP and global regulatory requirements.
• Willingness and ability to travel up to 50%.

Responsibilities of the Clinical Study Manager

The specific duties of the Clinical Study Manager include but are not limited to:

Clinical Operations Leadership

• Lead the planning start-up execution monitoring and close out of large complex prospective clinical studies including RCTs.
• Serve as the study level operational owner accountable for timelines quality compliance and execution excellence.
• Translate protocol intent and regulatory requirements into robust executable clinical operations strategies.

Study Planning & Execution

• Develop and execute comprehensive:
  • Clinical Operations Plans
  • Monitoring Plans
  • Vendor Oversight Plans
  • Recruitment and retention strategies
  • Study timelines budgets and resourcing plans
  • Ensure study conduct aligns with protocol SAP investigational plan and regulatory commitments.

Quality Compliance and Inspection Readiness

• Ensure continuous compliance with:

• ICHGCP
• FDA and OUS regulatory requirements
• Internal SOPs and quality standards

• Proactively identify and mitigate risks to subject safety data integrity and regulatory compliance.
• Lead and support audit and inspection readiness responses and CAPA development.

Vendor & Site Oversight

• Lead selection onboarding and oversight of CROs and other clinical vendors.
• Drive vendor performance through KPIs issue escalation and corrective actions.

• Oversee site selection activation and ongoing performanceincluding the performance of on-site visits enrollmenttracking monitoring quality protocol adherence.

Team Leadership & Mentorship

• Provide leadership mentoring and professional guidance to CRAs and study team members.
• Serve as a role model for bestinclass clinical operations conduct documentation quality and ethical decision
• Contribute to SOPs work instructions templates and training materials.

Location

111 West Oak Ave. Tampa FL 33602

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Benefits/Compensation

Axogen follows healthcare system guidelines with respect to credentialing vaccinations and other employment/compliance related requirements as well as CDC guidance. Axogen reserves the right to amend its policies from time to time in its sole discretion.