Senior Manager, Clinical Operations

About Us

Cerapedics is a global, commercial-stage orthopedics company 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 its 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.

About the Role

Healing lives through bone repair – this mission inspires us every day. In this role as Senior Manager, Clinical Operations, you will contribute to our mission by leveraging extensive experience to ensure high-quality, compliant, collaborative, and efficient conduct of pre- and post-market clinical trials. As part of the Clinical Affairs team, you will provide operational management of the Company’s clinical studies from initiation through close-out, supporting data dissemination activities, and applying deep knowledge of clinical regulations and best practices.

A typical day includes managing study initiation through close-out, collaborating with executive leadership, healthcare professionals, and research staff.

Responsibilities

• Oversee and manage all operational aspects of Cerapedics clinical studies and clinical evidence generation in the USA.
• Contribute to the development of clinical evidence strategies to maximize opportunities for data generation.
• Design, plan, and implement clinical research projects in accordance with national regulations, ICH-GCP, and ISO 14155 requirements.
• Manage all clinical study project elements from initiation to close-out, emphasizing study start-up, training, and education of investigators and research staff.
• Work collaboratively with CROs to manage and execute the clinical strategic operations plan, including timelines, resources, and cost.
• Monitor study progress and collaborate with CROs and third-party vendors to ensure timely execution, adherence to protocol, budgets, and compliance requirements.
• Collaborate closely with 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.

Requirements

• Bachelor’s degree in a relevant science or healthcare-related subject. Postgraduate qualification beneficial.
• Preferred 8+ years of clinical trials experience (orthopedics or related discipline preferred) and demonstrated commitment to continued professional development.
• Experience in managing publications, medical writing, and external scientific communications.
• Experience with orthopedics or spinal medical devices is highly desirable.
• Strong analytical and problem-solving skills.
• Ability to manage timelines and multiple priorities under time constraints.
• Ability to work effectively in a cross-functional environment.
• Self-motivated, assertive, and able to approach tasks with a positive ‘can-do’ attitude.
• Ability to cultivate and maintain relationships with thought leaders and establish trust through scientific expertise and follow-through.
• Strong leadership skills and the ability to compile and disseminate information clearly to ensure a cohesive understanding of project status and direction.
• Excellent communication skills, diplomacy, and the ability to combine science with relationship building.

Work Conditions / Physical Demands

The physical demands described are representative of those required to successfully perform the essential functions of the job. Reasonable accommodation may be provided when requested to enable individuals with disabilities to perform these functions.

• Regularly utilize written and verbal communication skills, including active listening and speaking clearly.
• Periods of prolonged sitting, with occasional standing, walking, carrying items, climbing, reaching, and lifting up to 20 lbs.
• Operate office equipment such as telephones, computers, fax machines, and copiers, requiring manual dexterity and hand/finger coordination.

Moderate to minimal supervision is provided. A wide degree of latitude is expected, relying on experience and judgment to plan and accomplish goals.

Travel Requirements

Up to 40% travel required. Corporate offices are in Westminster, CO, and travel to this location is required as needed. The position can be primarily remote.

Benefits

• Medical and dental insurance
• Group life insurance
• 401k matching
• Long-term disability
• Potential target bonus
• Paid time off

Pay

Base Salary: $146,000.00 - $210,000.00 annually

Annual Target Bonus: Up to 20%