Senior Manager, Clinical Operations

ABOUT US

Cerapedics is a global, commercial-stage orthopedics company that is dedicated to redefining the path to bone repair by healing bones faster and at higher rates, so all patients can get back to living their fullest lives. Bone grafts, including Cerapedics’ products, are used in over four million annual spine, orthopedics, trauma, and interventional procedures worldwide. Cerapedics has two drug-device products approved by the FDA powered by Cerapedics’ proprietary P-15 Osteogenic Cell Binding Peptide: PearlMatrix™ Bone Graft for all major lumbar interbody surgical approaches and i-FACTOR® Bone Graft for single-level anterior cervical discectomy and fusion (ACDF) in the cervical spine. Cerapedics is headquartered in Westminster, Colorado.

OVERVIEW

Healing lives through bone repair – this mission is what inspires us every day. If that is inspiring to you as well, consider joining us as a Senior Manager, Clinical Operations.

In this role, you will contribute to our mission through drawing upon extensive experience to ensure high-quality, compliant, collaborative, and efficient conduct of pre- and post-market clinical trials. As a Senior Manager, Clinical Operations working on the Clinical Affairs team, you will be empowered through meaningful work and career development to provide operational management of the Company’s clinical studies from study initiation through to close-out and supporting data dissemination activities and requires deep knowledge and understanding of clinical regulations and best practices. A typical day will include- managing study initiation through close-out and supporting activities, collaborating with executive leadership, healthcare professionals, and research staff.

POSITION OBJECTIVES:

• Oversee and manage all operational aspects relating to Cerapedics clinical studies and clinical evidence generation in the USA.
• Contribute to the development of clinical evidence strategies to maximize opportunities for data generation.
• Contributes to the development of trial strategies and refinement to ensure high-quality and efficient trial execution.
• Design, plan and implement clinical research projects in accordance with national regulation, ICH-GCP and ISO 14155 requirements.
• Manage all clinical study project elements from initiation to close-out with an emphasis on study start-up ensuring training and education of investigators and research staff.
• Work collaboratively with CRO to manage and execute the clinical strategic operations plan for projects including timelines, resources and cost.
• Monitor study progress and collaborate with CRO and third-party vendors to ensure timely execution of projects and adherence to protocol, budgets and compliance requirements.
• Collaborate closely with both internal and external stakeholders including Regulatory Affairs, Legal, Medical Affairs, Senior Leadership, study investigators and site research staff.
• Support data dissemination activities and communication of clinical study outcomes to internal stakeholders.
• Perform other reasonably related activities as requested.