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Clinical Research Manager – Orthopedics – Remote – 3692018

Join a publicly traded orthopedic biologics company seeking a Clinical Research Manager to support an expanding North American clinical research program. This highly visible role will be responsible for managing post-market clinical studies, partnering with investigators and CROs, and ensuring the successful execution of clinical research initiatives that support the company’s growing portfolio of orthobiologic technologies. The ideal candidate will combine strong clinical operations experience with a passion for advancing evidence-based patient care through high-quality clinical research.

The company is continuing to expand its clinical research efforts in North America and is investing heavily in both company-sponsored and investigator-initiated studies. This hire will play a critical role in supporting upcoming post-market clinical studies while collaborating with key opinion leaders, clinical sites, and cross-functional partners to ensure study success.

Responsibilities:

• Oversee and manage clinical studies across orthopedic and trauma-related indications.
• Serve as the primary liaison between the company, clinical investigators, and contract research organizations (CROs).
• Manage clinical study administration, monitoring activities, and study execution.
• Support and oversee site monitoring activities, trial master file management, and clinical documentation.
• Ensure compliance with Good Clinical Practice (GCP), FDA regulations, company SOPs, and applicable regulatory requirements.
• Assist in developing and implementing clinical processes, procedures, and study-related programs.
• Monitor study timelines, budgets, enrollment goals, and key project milestones.
• Support communications with surgeon investigators, research coordinators, and clinical stakeholders.
• Track study progress and provide updates to internal leadership and Medical Affairs teams.
• Partner closely with Medical Affairs leadership to ensure successful study execution and data collection.

Qualifications:

• 5+ years of clinical research experience within medical devices, pharmaceuticals, biotechnology, or related healthcare industries.
• Experience as a Clinical Research Associate (CRA) with readiness to advance into a Clinical Research Manager role, or prior Clinical Research Manager experience.
• Working knowledge of FDA regulations, ICH-GCP guidelines, and clinical trial management processes.
• Experience managing investigator sites and CRO relationships.
• Proficiency with EDC platforms and clinical data collection systems.
• Experience working directly with physician investigators and key opinion leaders (KOLs). Orthopedic surgeon interaction is preferred but not required.
• ACRP or SOCRA certification preferred.
• Master’s degree in Nursing or related clinical discipline preferred.
• Strong organizational, project management, and communication skills.
• Ability to manage multiple studies and priorities simultaneously.

Compensation:

• Base Salary: Competitive
• Comprehensive Benefits Package
• Location: Remote (FL, TX, or MA preferred)
• Approximately 50% travel required.

The job description is not exhaustive and may have been condensed for online or mobile viewing. It does not encompass all duties, responsibilities, or aspects of the job and is subject to amendments at the sole discretion of the Employer. Employees may also perform other related duties as needed to support the organization.

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