Clinical Research

• Manage all clinical operational and quality aspects of allocated studies, of low to moderate complexity, in compliance with ICH GCP
• Develop clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan
• Contribute to the development of the Master Action Plan (MAP) for providing clinical related documents
• Ensure timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central)
• Collaborate with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings
• Collaborate with the clinical team and other departments as needed to meet deliverables of the project
• Regularly communicate with the team and lead team meetings to ensure that timelines, resources, interactions, and quality are maintained
• Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies
• Responsible for the timely archiving of documents and study materials for the department
• Ensure achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution
• Continuously monitor or co-monitor clinical trials to assess performance and ensure contractual obligations are met
• May communicate with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues
• May coordinate all start-up activities and ensures that timely ethics committee and regulatory submissions (if appropriate) are addressed
• Ensure that essential document quality meets the expectation of Regulatory Compliance Review
• Review and follows up on all questions raised by the ethics committees
• May provide input into preparation of forecast estimates for clinical activities
• Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements

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Clinical Trial Manager