Senior Associate I, TMF Operations

Role Overview

• Perform RMC Lead Activities for 1-3 Studies
• Support TMF set-up, coordinate ‘Requests for Sites to be added in eTMF’ between Project Teams (PT) and eTMF administrators
• Review eTMF access and coordinate updates, as necessary
• Provide Subject Matter Expert (SME) support for Project Teams and Sponsor related to TMF
• Oversee the QC process and make sure the RMC is on track (compliant with timelines and documentation) and follow up on non-compliance accordingly
• Prepare, maintain, and share TMF metrics and spreadsheets for assigned studies with Project Teams and Sponsors
• Review TMF Key Performance Indicators (KPIs) and ensure that TMF KPIs are in compliance
• Support Regulatory and Sponsor audits and audits finding resolution, where necessary

Requirements

• University Degree preferred (Life Science desirable)
• 1-3 years of relevant experience
• Knowledge of working within a highly regulated industry or experience of CRO/Pharmaceutical Industry
• Excellent written and verbal communication skills
• Strong interpersonal skills
• Ability to handle multiple, highly detailed tasks with exceptional accuracy
• Strong planning and organizational skills
• Proficiency in Microsoft Word and Excel

Benefits

• Health insurance
• Professional development opportunities
• Flexible working hours
• Remote work options