TMF Document Specialist (TMF experience needed)

Job description

• Process documents into eTMF system following guidance, to the required quality and productivity levels, across multiple clients.
• Remap documents across TMF structures according to client-specific guidance and Company SOPs.
• Perform Quality Review across multiple core clients, to the required quality and productivity levels.
• Remediation of TMF to include query analysis and resolution, and ongoing TMF maintenance.
• Archive preparation, to include inventory review and completion, tracking of paper and box handling.
• Identify opportunities for process improvement.

With the appropriate training and experience:

• Coach and mentor small groups of people.
• Coordinate allocation of work across a team.
• Use inhouse generated MI to facilitate continuous improvement in quality, productivity and other KPI’s.
• Perform analysis of Heatmap data and provide expert advice to client on TMF health.

Requirements

• Have excellent working knowledge of Trial Master File documentation, eTMF Systems and TMF structures.
• Excellent attention to detail and organisational skills.
• Can work to deadlines in a fast paced environment and prioritise, multitask and reschedule tasks as appropriate.
• Ability to make decisions independently, using a flexible approach.
• Willingness to embrace change and work collaboratively.
• IT experience including basic MS Office (Word, Excel).