Clinical Study Manager
Axogen Inc.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! Â
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.Â
 Why you’ll love working at Axogen:Â
- Friendly, open, and fun team culture that values unique perspectivesÂ
- Company-wide dedication to profoundly impacting patients’ livesÂ
- Comprehensive, high-quality benefits package effective on date of hireÂ
- Educational assistance available for all employeesÂ
- Matching 401(k) retirement planÂ
- Paid holidays, including floating holidays, to be used at your discretionÂ
- Employee Stock Purchase PlanÂ
- Referral incentive programÂ
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 leads the planning, implementation, execution, monitoring, and close-out of Axogen sponsored clinical studies. This position ensures adherence to applicable regulations, Good Clinical Practices, and industry standards governing research involving human subjects; and ensures that clinical studies achieve company objectives on-time and within budget.
Requirements of the Clinical Study Manager
- Bachelor’s degree (or higher) in a medical, scientific, or engineering discipline; (or commensurate combination of training and experience);
- Minimum of 3 years of experience in industry sponsored clinical Prior experience in project management and/or as a Clinical Research Associate is strongly preferred;
- Prior experience with medical device studies is strongly preferred;
- Familiarity with applicable regulations, Good Clinical Practices, and industry standards governing clinical research and the protection of human subjects;
- Strong critical thinking and discretionary decision-making skills;
- Strong organizational, analytical, and time-management skills;
- Ability to multi-task and prioritize autonomously;
- Excellent written & oral communication skills;
- Ability and willingness 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:
- Leading the day-to-day operations of assigned clinical studies;
- Serving as the study manager and primary point of contact for assigned clinical studies and managing clinical vendors such as Contract Research Organizations
- Representing Clinical Operations and providing subject matter expertise on cross-functional multi-disciplinary project teams
- Leading the identification, selection, and management of clinical study sites
- Leading the identification, selection, and management of associated clinical vendors, such as Contract Research Organizations, through applicable internal approvals
- Leading the development of clinical study protocols and investigational plans, case report forms and other study-specific documents (e.g., monitoring report templates, informed consent forms, monitoring plans; study guides; presentations/training materials; clinical study reports, etc.)
- Driving recruitment and operational excellence to ensure data quality and integrity and to ensure compliance with the study protocol, investigational plan, applicable regulatory requirements, and Good Clinical Practices
- Coordinating communications with study investigators and site personnel (e.g., developing study newsletters, etc.)
- Developing and managing study budgets, project timelines, progress reports, and corrective action plans to ensure that clinical studies achieve company objectives on-time and within budget
- Managing, mentoring, and/or training Clinical Research Associates
- Assisting with the development of effective Standard Operating Procedures, work instructions, and job aides for use by the clinical research team
- Assisting in planning and execution of investigator meetings
- Coordinating the identification and selection of clinical vendors
- Monitoring clinical trials through all phases
- Reading and critically interpreting relevant literature and serving as a resource for clinical knowledge of assigned therapeutic areas;
- Ensuring timely subject recruitment and smooth implementation of studies by leading, guiding and motivating site personnel to achieve study goals
- Assisting with review, routing, and approval of clinical trial agreements and site activation documentation
- Presenting study information and data at investigator meetings, team meetings, and executive leadership reviews
- Assisting with preparation of Ethics Committee submissions and notifications/submissions to federal and state regulatory authorities
- Collaborating with other Axogen departments as applicable (ex: Clinical Sciences, Marketing, Medical Affairs, etc)
- Participating in internal and external audits
Location
111 West Oak Ave., Tampa, FLÂ 33602
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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.
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.