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.
• 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.
• Regularly communicate with the team and lead team meetings to ensure that timelines, resources, interactions, and quality are maintained.
• Ensure achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics.
• Continuously monitor or co-monitors clinical trials to assess performance and ensure contractual obligations are met.
• Coordinate all start-up activities and ensure that timely ethics committee and regulatory submissions are addressed.
• Review and follow up on all questions raised by the ethics committees.

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