Position Overview:The Clinical Study Administrator will play a crucial role in the execution and management of clinical studies for medical device development. This position will ensure the smooth administration of clinical trials through document development, site management, budget oversight, safety coordination, and effective communication with internal and external stakeholders.Key Responsibilities:Development of Study Documents:Prepare and maintain essential clinical trial documentation, including safety management plans, study protocols, informed consent forms, case report forms (CRFs), monitoring plans, study manuals, investigator brochures, and annual reports.Site Management and Monitoring:Oversee clinical trial sites, conduct site monitoring activities, and ensure compliance with study protocols and regulatory requirements.Budget Tracking and On-Site Payments:Manage budget-related tasks, track study-related expenditures, and coordinate timely on-site payments.Clinical Data Review:Support the collection, verification, and review of clinical data for accuracy, completeness, and readiness for analysis.Trial Registration, IRB Submissions, and Site Contracts:Coordinate the registration of trials on applicable platforms, prepare and submit documentation to Institutional Review Boards (IRBs), and assist with site contract negotiations and execution.Clinical Safety Coordination:Facilitate clinical trial safety processes through the creation and oversight of safety management plans and ensure proper reporting of safety events.Cross-Functional Communication:Collaborate effectively with global teams across clinical research, regulatory affairs, data management, and other key business functions to support study objectives.Qualifications:Bachelor's degree in life sciences, nursing, public health, or related field (advanced degrees preferred).Prior experience in clinical research administration, preferably in the medical device sector.Proven expertise in developing and managing clinical trial documentation.Hands-on experience with site management, monitoring practices, IRB submissions, and trial registrations.Skilled in budgeting, payment tracking, and data review.Strong interpersonal and communication skills for collaboration with cross-functional and global teams.Knowledge of regulatory guidelines (e.g., ICH-GCP, ISO and good clinical practice.