As the Clinical Operations Manager, you will be a pivotal force in overseeing clinical trials, ensuring regulatory compliance, and driving successful trial execution. Your role involves close collaboration with research teams, external vendors, and regulatory authorities to achieve our mission.
Day-to-Day Responsibilities:
- Protocol Development:
Collaborate with cross-functional teams to create, refine, and optimize clinical trial protocols.
Coordinate activities with external vendors, including Contract Research Organizations (CROs), clinical sites, and laboratories.
Foster strong relationships to ensure seamless trial execution. - Regulatory Compliance:
Maintain strict adherence to relevant regulations (e.g., FDA, ISO) throughout the trial lifecycle.
Accurately document all compliance-related activities. - Study Oversight:
Monitor study progress, patient recruitment, data collection, and safety reporting.
Address any deviations promptly. - Budget Management:
Track study budgets, negotiate contracts, and optimize resource allocation.
Ensure cost-effective trial management.
Identify potential risks and develop mitigation strategies.
Proactively address challenges to maintain trial integrity. - Quality Assurance:
Implement robust quality control measures.
Oversee site audits and ensure adherence to quality standards.
Manage and inspire clinical operations staff.
Foster a collaborative and efficient work environment.
Strategic Responsibilities:
- Process Optimization:
Continuously evaluate and enhance clinical trial processes.
Streamline workflows for maximum efficiency. - Innovation and Technology Integration:
Stay informed about emerging technologies and their impact on clinical operations.
Explore opportunities to integrate innovative tools into trial management. - Cross-Functional Collaboration:
Work closely with R&D, Regulatory Affairs, and Medical Affairs teams.
Leverage synergies to drive successful trial outcomes. - Patient-Centric Approach:
Champion patient safety and comfort throughout the trial journey.
Advocate for patient-centric practices.
Qualifications:
- Education: Bachelor’s degree in a relevant field (e.g., life sciences, healthcare administration).
- Experience: Minimum of 6 years in clinical operations within the medical device or pharmaceutical industry.
- Expertise:
Strong knowledge of Good Clinical Practice (GCP) regulations.
Familiarity with data integrity requirements and computer system validation.
Excellent communication, leadership, and problem-solving skills. - Adaptability: Ability to thrive in a dynamic environment and adapt to changing priorities.
Join Our Team!
Access Vascular, Inc. offers competitive compensation, comprehensive benefits, and exciting opportunities for professional growth. Be part of our dynamic team and contribute to advancing patient care through innovative medical technologies.
About Access Vascular
Access Vascular was founded in 2015 to address the most common and costly complications of intravenous therapy: infection, thrombosis, and phlebitis. The company is developing a suite of venous access devices made from patented biomaterials which are highly biocompatible and have demonstrated 6X fewer complications.
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