Senior Manager, Clinical Operations
Cerapedics Inc. · Westminster, CO · 2 wk ago
RemoteRemoteManagement$146k–$210k/yrFull-time
About the role
Cerapedics is a global, commercial-stage orthopedics company dedicated to redefining bone repair. The Senior Manager, Clinical Operations will contribute to this mission by ensuring high-quality, compliant, collaborative, and efficient conduct of pre- and post-market clinical trials.
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.
- Contribute 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.
- Maintain oversight of 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.
Position requirements
- Communicate succinctly, clearly and accurately in both verbal and written communications.
- Experience in managing publications, medical writing and external scientific communications.
- Experience with orthopedics or spinal medical devices is highly desirable.
- 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.
Educational and training requirements
- Bachelor’s degree in relevant science or healthcare related subject. Postgraduate qualification beneficial.
- Prioritization of 8+ years of clinical trials experience (orthopedics or related discipline preferred) and demonstrated commitment to continued professional development.
Work conditions/physical demands
- This position requires the incumbent to regularly utilize written and verbal communication skills, including active listening and speaking clearly and concisely.
- This position requires the incumbent to experience periods of prolonged sitting and to occasionally stand, walk, carry items, climb, reach, and lift up to 20 lbs.
- This position requires the incumbent to operate office equipment such as telephones, computers, fax machines, copiers, and to grasp objects utilizing manual dexterity including hand/finger coordination.
- Moderate to minimal supervision. A wide degree of latitude is expected. Relies on experience and judgment to plan and accomplish goals.
Benefits/compensation
- Medical and dental insurance, group life insurance, 401k matching, long term disability, potential target bonus, paid time off.
- SALARY RANGE: $146,000.00 - $210,000.00
- Base Salary: Annual
- Target Annual Bonus: Up to 20%
Position details
- The position will be posted through May 24, 2026.
- EEO Statement: Cerapedics is an Equal Opportunity Employer.