Provide Trial Master File (TMF) - Quality checks related assistance to study teams, ensuring work adheres to SOPs, policies, and regulatory requirements
Job Summary
Provide Trial Master File (TMF) - Quality checks related assistance to study teams, ensuring work adheres to SOPs, policies, and regulatory requirements.
Perform complex administrative tasks, update and maintain data in systems, and coordinate record retrieval and transfer to final destinations.
Interface with departments, serve as primary client contact, monitor filing accuracy, and manage scanning processes and training.
Matching Summary
Provide Trial Master File (TMF) - Quality checks related assistance to study teams, ensuring work adheres to SOPs, policies, and regulatory requirements.
Skills & Requirements
Must-have
Trial Master File (TMF) quality checks
records management systems administration
scanning processes management
client communication and support
filing accuracy and compliance monitoring
records center security maintenance
Nice-to-have
team leadership for projects
efficient maintenance of storage space
orderly imaging and transfer of records
Key Requirements
3-4 years' experience in Records Management
Knowledge of ICH and GCP regulations
Ability to handle multiple tasks and competing priorities
Strong organizational and planning skills
Excellent oral and written communication skills in English