Senior Manager, Clinical Operations

Cerapedics•Westminster, CO

1d•Remote

About The Position

Cerapedics is a global, commercial-stage ortho-biologics company that aspires to transform the standard of care for bone repair, healing bones faster and at higher rates, without compromising safety, so that patients can live their healthiest life. Bone grafts, including Cerapedics’ products, are used in over four million annual spine, orthopedics, trauma and interventional procedures world-wide. Cerapedics’ product, i-FACTOR, is FDA PMA approved for cervical use in the United States. Cerapedics’ next-generation product is currently being evaluated in lumbar interbody fusion through ASPIRE, a pivotal FDA IDE study and has been granted a Breakthrough Device Designation by the FDA. Cerapedics is headquartered in Westminster, CO. 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.

Requirements

Communicate succinctly, clearly and accurately in both verbal and written communications.
Experience in managing publications, medical writing and external scientific communications.
Ability to manage timelines, multiple priorities under time constraints.
Aptitude to develop technical expertise in new therapeutic area.
Strong analytical and problem-solving skills.
Ability to work effectively in a cross-functional environment.
Must be self-motivated, assertive and able to approach with a positive ‘can-do’ attitude.
Ability to cultivate and maintain relationships with thought leaders and to establish trust through the consistent demonstration of scientific expertise and satisfactory follow-through to requests from thought-leaders.
Strong leadership skills and the ability to compile and disseminate information to others in a cohesive fashion to assure a clear understanding of project status and direction.
Excellent communicator, skilled at diplomacy and capable of effectively combining science and relationship building.
Bachelor’s degree in relevant science or healthcare related subject.
Preferred 8 plus years of clinical trials experience (orthopedics or related discipline preferred) and demonstrated commitment to continued professional development.

Nice To Haves

Experience with orthopedics or spinal medical devices is highly desirable.
Postgraduate qualification beneficial.

Responsibilities

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.