Clinical Operations & Quality
This is an opportunity for an experienced clinical operations professional who enjoys stepping into complex, high-impact work and making an immediate difference. In this role, you’ll help guide post-acquisition clinical integration, close operational and quality gaps, and support compliant study execution across a dynamic environment where flexibility, collaboration, and sound judgment matter every day. The ideal background is someone who has worn multiple hats in a smaller or growing organization and is confident leading studies, partnering cross-functionally, overseeing vendors, and helping bring structure to evolving processes. If you thrive in hands-on work and want to contribute to meaningful clinical and quality improvements, this role offers exactly that.
- Lead clinical remediation and integration activities following acquisition due diligence and QMS assessments.
- Support the transition of active clinical studies to ensure continuity, compliance, and minimal disruption.
- Collaborate with Clinical, Quality, Regulatory, Data Management, Medical Affairs, and other cross-functional teams to address process and compliance gaps.
- Serve as a subject matter expert for clinical operations during post-acquisition integration.
- Review clinical procedures, study documentation, vendor oversight practices, TMF content, and operational processes to identify improvement opportunities.
- Provide hands-on support for clinical study planning and execution.
- Oversee CRO and vendor management activities.
- Support clinical monitoring oversight and issue resolution.
- Coordinate with Data Management on study-related activities and deliverables.
- Manage clinical documentation and TMF maintenance to ensure inspection readiness.
- Assess operational risk and help develop mitigation strategies.
- Develop, revise, and implement SOPs, work instructions, templates, and supporting documentation.
- Coach acquired entity personnel on clinical operations best practices and quality system expectations.
- Partner with project teams to track remediation activities through completion.
- Keep Clinical Leadership and Integration Management informed on progress, risks, dependencies, and recommendations.
- Participate in internal audits and inspections as needed.
- Maintain compliant documentation and ensure all work aligns with applicable QMS requirements and regulatory standards.
- Bachelor’s degree required
- Located in the Eastern or Central time zone of the United States or Canada
- Available for 100% utilization
- Strong background in clinical operations, quality, or related clinical development functions
- Experience working in small, start-up, or growing company environments where flexibility and cross-functional support are essential
- Demonstrated ability to manage multiple priorities independently
- Experience with clinical study oversight, vendor management, data management coordination, and TMF/documentation processes
- Working knowledge of FDA, ICH-GCP, ISO 14155, MDR, and other applicable regulatory frameworks
- Experience supporting quality remediation, process improvement, or integration activities is strongly preferred
- Ability to collaborate effectively across Clinical, Quality, Regulatory, Data Management, and Medical Affairs teams
- Strong communication, problem-solving, and organizational skills
- Ability to operate within more than one Quality Management System
- Competitive Hourly Rate