Clinical Study Manager

Lead the end-to-end management of clinical studies, from study planning to close-out.
Ensure compliance with regulatory requirements through site monitoring, training, audits, and data verification.
Collaborate with investigators and study sites, providing guidance on protocols and regulatory expectations.
Act as the clinical and regulatory expert on GCP, ISO, and FDA requirements for medical device studies.
Review study documentation, monitor data quality, resolve study issues, and ensure accurate reporting.
Develop study protocols and optimize clinical research processes to improve efficiency and data quality.
Manage timelines, budgets, risks, and study progress, proactively addressing deviations.
Work closely with cross-functional teams including Regulatory Affairs, R&D, Quality, Marketing, Biostatistics, Data Management, Clinical Development, and Health Economics & Market Access (HEMAR) .
Use clinical trial systems such as EDC, eTMF, and CTMS to manage study execution.