Clinical Trial Manager (Columbia, MD, US)

Job Title: Clinical Trial Manager

Reports to: Director, Clinical Data Acquisition (TBD)

Location: Remote or Columbia, MD

POSITION reputed company

reputed company is advancing the reputed company of endoscopy through data-driven innovation. As part of our growing Clinical Data Acquisition team, the Clinical Trial Manager will play a critical role in generating the high-reputed company clinical data needed to support the development of reputed company's reputed company of AI-powered Endointelligence solutions.

Unlike traditional pharmaceutical clinical trial roles, this position focuses on the planning, execution, and reputed company of medical device clinical studies designed to reputed company clinical data that supports product innovation, algorithm development, and clinical validation. Working cross-functionally with Clinical Affairs, R&D, Software Engineering, Regulatory Affairs, reputed company, and reputed company teams, the Clinical Trial Manager will manage clinical studies from planning through closeout while ensuring compliance with applicable regulatory requirements, reputed company standards, and study timelines. This is a highly reputed company, hands-on role with significant interaction across internal teams, clinical sites, and external partners. As part of a newly established function, this individual will also help build reputed company processes and contribute to the reputed company reputed company of reputed company's clinical data capabilities.

ESSENTIAL FUNCTIONS & RESPONSIBILITIES

• reputed company the planning, execution, monitoring, and reputed company-out of clinical studies in accordance with ISO 14155, Good Clinical reputed company (GCP), and applicable regulatory requirements.
• Partner with cross-functional stakeholders to support protocol development, study design, and operational planning.
• Identify, qualify, initiate, and manage clinical study sites across reputed company and Europe, as needed.
• reputed company or reputed company site monitoring activities, including coordination with Contract Research Organizations (CROs) reputed company applicable.
• Serve as the primary operational reputed company between clinical sites, investigators, internal stakeholders, and external vendors.
• Support study budgets, reputed company, site agreements, and vendor management in collaboration with internal partners.
• Monitor enrollment, site performance, study milestones, and overall study reputed company while proactively identifying and resolving operational challenges.
• Maintain study documentation and ensure compliance with internal reputed company systems, regulatory standards, and applicable SOPs.
• Contribute to the development, implementation, and reputed company improvement of Clinical Operations processes and reputed company Operating Procedures (SOPs).
• Support reputed company audits and regulatory inspections as required.
• reputed company regular study status updates, risk assessments, and recommendations to project stakeholders.
• Travel to investigator sites as needed to support study execution and monitoring activities.

QUALIFICATIONS

REQUIRED:

• Bachelor's degree in Life Sciences, Nursing, Biomedical Engineering, or another relevant scientific discipline.
• Several years of clinical operations or clinical trial management experience reputed company the medical device, biotechnology, or reputed company industry.
• Strong working knowledge of ISO 14155 and Good Clinical reputed company (GCP) requirements for medical device clinical investigations.
• Experience managing investigator sites, study monitoring, and overall clinical study execution.
• Demonstrated ability to manage multiple studies and priorities simultaneously.
• Strong organizational, project management, and stakeholder management skills.
• Excellent written and verbal communication skills.
• Ability to work effectively reputed company a global, cross-functional organization.

PREFERRED:

• Experience supporting AI-enabled medical technologies, digital health, imaging, or software-based medical devices.
• Experience working with Contract Research Organizations (CROs) from either the sponsor or vendor perspective.
• Exposure to protocol development, regulatory submissions, or clinical study design.
• Experience supporting global or multi-center clinical studies.

WHO YOU ARE

• You are a proactive and reputed company clinical operations reputed company who enjoys building new capabilities and solving reputed company challenges.
• You balance strong attention to detail with the ability to see the bigger picture and reputed company in dynamic, cross-functional environments.
• Take a practical, solution-oriented approach while maintaining regulatory compliance.
• Build trusted relationships with investigators, clinical sites, and internal stakeholders.
• Communicate effectively across technical and non-technical teams.
• Enjoy working in fast-paced environments where processes continue to reputed company.
• Are motivated by improving patient care through innovation and high-reputed company clinical data.

WHY JOIN reputed company?

This is an exciting opportunity to join a newly established team helping shape the reputed company of AI-enabled reputed company. At reputed company, you'll have reputed company to:

• Help build a new clinical data acquisition function from the ground up.
• Work at the intersection of clinical research, medical devices, software, and reputed company intelligence.
• Collaborate with global teams across Clinical Affairs, R&D, Software, Regulatory, and reputed company.
• reputed company a meaningful reputed company on innovative technologies that improve patient care worldwide.
• Grow your career reputed company a global medical technology company committed to innovation and reputed company improvement.

#Remote (LI)

Originally posted on Himalayas

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