Clinical Study Manager

Overview 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 You’ll Love Working At Axogen Friendly, open, and fun team culture that values unique perspectives Company-wide dedication to profoundly impacting patients’ lives Comprehensive, high-quality benefits package effective on date of hire Educational assistance available for all employees Matching 401(k) retirement plan Paid holidays, including floating holidays, to 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 end‑to‑end operational leadership of an Axogen‑sponsored 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 cross‑functional 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 Bachelor’s degree or higher in a scientific, medical, or engineering discipline (or equivalent experience). Minimum 5 years of industry‑sponsored 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 ICH‑GCP 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: ICH‑GCP 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 performance, including the performance of on-site visits, enrollment tracking, 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 best‑in‑class clinical operations conduct, documentation quality, and ethical decision‑making. Contribute to SOPs, work instructions, templates, and training materials. Location 111 West Oak Ave., Tampa, FL 33602 Benefits/Compensation This position is eligible for an annual bonus. Benefits offered for this position include Health, Dental, Vision, Matching 401K, Paid Time Off, 9 Paid Holidays + 3 Floating Holidays, Dependent Care Flexible Spending Accounts, Medical Flexible Spending Accounts, Tuition Reimbursement, Paid Parental Leave, Paid Caregiver Leave, Basic Life Insurance, Supplemental Life Insurance, Employee Stock Purchase Plan, and Disability Insurance, as described in more detail in summary plan descriptions. Salary Range $113,903—$142,378 USD 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. #J-18808-Ljbffr