[Remote] Clinical Trial Manager
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is advancing the reputed company of endoscopy through data-driven innovation. The Clinical Trial Manager will manage clinical studies from planning through closeout while ensuring compliance with regulatory requirements and reputed company standards, working collaboratively with various internal teams and external partners.
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
Skills
- 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
- 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
reputed company