AxoGen (AXGN) is a global leader in innovative surgical solutions for peripheral nerve injuries. AxoGen is focused on the science, development and commercialization of technologies for peripheral nerve regeneration and repair. Peripheral nerves provide the pathways for both motor and sensory signals throughout the body. Every day, people suffer traumatic injuries or undergo surgical procedures that impact the function of their peripheral nerves. Damage to a peripheral nerve can result in the loss of muscle or organ function, the loss of sensory feeling or the initiation of pain. Injuries to peripheral nerves can significantly impact the patient’s quality of life.
AxoGen's portfolio of products includes Avance® Nerve Graft, an off-the-shelf processed human nerve allograft for bridging severed nerves without the comorbidities associated with a second surgical site, AxoGuard® Nerve Connector, a porcine submucosa extracellular matrix ("ECM") coaptation aid for tensionless repair of severed nerves, AxoGuard® Nerve Protector, a porcine submucosa ECM product used to wrap and protect injured peripheral nerves and reinforce the nerve reconstruction while preventing soft tissue attachments and Avive™ Soft Tissue Membrane, a minimally processed human umbilical cord membrane that may be used as a soft tissue covering to reduce inflammation and scar tissue formation. Along with these core surgical products, AxoGen also offers AxoTouch™ Two-Point Discriminator and AcroValTM Neurosensory & Motor Testing System. These evaluation and measurement tools assist healthcare professionals in detecting changes in sensation, assessing return of sensory, grip and pinch function, evaluating effective treatment interventions, and providing feedback to patients on nerve function. The AxoGen portfolio of products is available in the United States, Canada, the United Kingdom and several European and international countries.
AxoGen maintains its corporate offices in Alachua, Florida.
AxoGen provides a great work environment that includes a fast-paced innovative team with a strong commitment to restoring quality of life to patients with nerve injuries.
The Clinical Research Manager assists in the design, preparation, planning, implementation, and review of clinical trials. As a member of the Clinical and Translational Sciences team, this position will support both sponsored and investigator initiated clinical studies with AxoGen technologies while ensuring adherence to institutional, local, federal, state, and company ethical standards. The Clinical and Translational Sciences is composed of Clinical Research, Clinical Affairs, Translational Sciences, Product Development and Professional Education. Members of the team provide scientific expertise for internal and external projects and will interface with cross-functional teams, thought leaders, academic researchers, subject-matter experts, clinicians, surgeons, and regulatory agencies. This position offers a unique combination of clinical project management and clinical affairs, in a collaborative team environment that drives results.
EDUCATIONAL REQUIREMENTS/ QUALIFICATIONS
- Minimum of BS is Life Sciences or Mathematics.
- Minimum of
2 yearexperience in the conduct and management of clinical trials.
- Strong sense of pride in your work product.
- Ability to take ownership in a project and drive it to completion.
- Passion for advancing scientific knowledge.
- Awareness of the impact of your contributions on your team, the company, collaborators, customers, patients, medical science and society.
- Serve as primary point of contact for assigned clinical studies.
- Participate in project team meetings and provides clinical representation.
- Participate in identification, evaluation, and selection of clinical study sites and investigators.
- Develop, or assist with
developmentof study design, protocols, case report forms and other study-specific documents essential to appropriate implementation of clinical investigations.
- Work with investigators to ensure optimal compliance and performance to the protocol, regulatory requirements, discrepancy reporting and ethical practice. Assist with preparation and execution of Investigator meetings.
- Ensure International Conference on
Harmonization,and Good Clinical Practice procedures are followed in all study aspects.
- Participate in vendor selection, and establish plans for data processing and data review with vendors. Manage Clinical Project Managers and/or Clinical Research Associates.
- Manage Clinical Research Organizations and consultants.
- Monitor clinical trials through all phases.
We are seeking candidates who are AxoGenic, which means:
- Respect is the foundation for communication and action.
- Patient safety is our first priority.
- In being effective stewards of the gift of human tissue.
- In creating and maintaining a company culture that encourages and rewards honesty, openness, passionate debate – and fun!
- Individual ownership and empowerment lead to superior team results.
- The organization, its
membersand partners must consistently achieve agreed upon results with flexibility and mutual support.
- Speed is critical!