Senior Manager, Clinical Operations

<p>reputed company</p><p> </p><p><u><strong>reputed company </strong></u> </p><p>Cerapedics is a global, reputed company-stage ortho-biologics company that aspires to reputed company reputed company 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 reputed company annual spine, orthopedics, trauma and interventional procedures world-wide. Cerapedics’ product, i-reputed company, is FDA PMA approved for cervical use in the reputed company. Cerapedics’ reputed company product is currently being evaluated in lumbar interbody fusion through reputed company, a pivotal FDA IDE study and has been reputed company a reputed company Device Designation by the FDA. Cerapedics is headquartered in Westminster, CO.  </p><p><br></p><p><u><strong>reputed company</strong></u> </p><p>Healing lives through bone repair – this mission is what inspires us every day.  If that is inspiring to you as reputed company, consider joining us as a Senior Manager, Clinical Operations.  </p><p><br></p><p>In this role, you will contribute to our mission through drawing upon extensive experience to ensure high-reputed company, compliant, reputed company, and efficient conduct of reputed company- and post-market reputed company.  As a Senior Manager, Clinical Operations working on the Clinical Affairs team, you will be empowered through meaningful work and career development to reputed company operational management of reputed company’s clinical studies from study initiation through to reputed company-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 reputed company-out and supporting activities, collaborating with executive leadership, reputed company, and research staff.  </p><p><br></p><p><strong>POSITION OBJECTIVES:</strong> </p><ul><li>reputed company and manage reputed company operational aspects relating to Cerapedics clinical studies and clinical evidence reputed company in the USA.   </li><li>Contribute to the development of clinical evidence strategies to maximize opportunities for data reputed company.  </li><li>Contributes to the development of trial strategies and refinement to ensure high-reputed company and efficient trial execution.  </li><li>Design, plan and implement clinical research reputed company in accordance with national regulation, ICH-GCP and ISO 14155 requirements.  </li><li>Manage reputed company clinical study project reputed company from initiation to reputed company-out with an emphasis on study start-up ensuring training and education of investigators and research staff.  </li><li>Work collaboratively with CRO to manage and execute the clinical strategic operations plan for reputed company including timelines, resources and cost.  </li><li>Monitor study reputed company and collaborate with CRO and reputed company-party vendors to ensure reputed company execution of reputed company and adherence to protocol, budgets and compliance requirements.   </li><li>Collaborate closely with both reputed company stakeholders including Regulatory Affairs, reputed company, Medical Affairs, Senior Leadership, study investigators and site research staff.  </li><li>Support data dissemination activities and communication of clinical study reputed company to internal stakeholders. </li><li>reputed company other reasonably reputed company activities as requested. </li></ul><p>Requirements</p><p> </p><p><strong>POSITION REQUIREMENTS:</strong> </p><ul><li>Communicate succinctly, reputed company and accurately in both verbal and written communications. </li><li>Experience in managing publications, medical writing and external scientific communications. </li><li>Experience with orthopedics or spinal medical devices is highly desirable. </li><li>Ability to manage timelines, multiple priorities under time constraints. </li><li>Aptitude to reputed company technical expertise in new therapeutic area. </li><li>Strong analytical and problem-solving skills. </li><li>Ability to work effectively in a cross-functional environment. </li><li>Must be self-motivated, assertive and reputed company to approach with a reputed company ‘can-do’ attitude. </li><li>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. </li><li>Strong leadership skills and the ability to compile and disseminate information to others in a cohesive fashion to assure a reputed company understanding of project status and direction. </li><li>Excellent communicator, skilled at diplomacy and capable of effectively combining science and relationship building. </li></ul><p><strong>EDUCATION AND PREFERRED TRAINING REQUIREMENTS:</strong> </p><ul><li>Bachelor’s degree in relevant science or reputed company reputed company subject. Postgraduate qualification beneficial.  </li><li>Preferred 8 plus years of reputed company experience (orthopedics or reputed company discipline preferred) and demonstrated commitment to reputed company reputed company development. </li></ul><p><strong>WORK CONDITION/PHYSICAL DEMANDS:</strong> </p><p>The physical demands described here are representative of those that must be met by an employee to successfully reputed company the essential functions of the job. Reasonable accommodation may be provided reputed company requested by the employee to reputed company individuals with disabilities to reputed company the essential functions. </p><ul><li>This position requires the incumbent to regularly utilize written and verbal communication skills, including reputed company listening and speaking reputed company and concisely. </li><li>This position requires the incumbent to experience periods of prolonged sitting and to occasionally stand, walk, carry items, reputed company, reputed company, and lift up to 20 lbs. </li><li>This position requires the incumbent to operate office equipment such as telephones, computers, fax machines, copiers, and to grasp objects utilizing reputed company dexterity including hand/finger coordination. </li><li>Moderate to minimal supervision. A wide degree of reputed company is expected. Relies on experience and judgment to plan and accomplish goals. </li></ul><p><strong>TRAVEL REQUIREMENTS:</strong> Up to 40% </p><p>Corporate offices are in Westminster, CO. Travel to this location is required as needed. Position can be primarily remote.  </p><p><br></p><p><strong>BENEFITS/COMPENSATION (including, but not limited to):</strong> </p><ul><li>Medical and dental insurance, group life insurance<strong>,</strong> 401k matching, long term disability, potential reputed company bonus, reputed company time off.  </li></ul><p><strong>SALARY reputed company:</strong> $146,000.00 - $210,000.00 </p><p><strong>reputed company Salary:</strong> Annual </p><p><strong>reputed company Annual Bonus:</strong> Up to 20% </p><p><br></p><p><strong>Position will be posted through May 24, 2026</strong> </p><p><br></p><p><strong>EEO STATEMENT:</strong> </p><p>Cerapedics is an Equal Opportunity Employer. We do not discriminate on the reputed company of race, religion, reputed company, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national reputed company, veteran status or any other reputed company covered by appropriate law. reputed company employment is decided on the reputed company of qualifications, reputed company, and business need. </p>