[Hiring] Senior Associate I, TMF Operations @Worldwide Clinical Trials

Role Description

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 ensure 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 audit finding resolution, where necessary.

Qualifications

• Excellent written and verbal communication skills to clearly and concisely present information.
• Strong interpersonal skills.
• Ability to handle multiple, highly detailed tasks with exceptional accuracy.
• Strong planning and organizational skills.
• Proficiency in Microsoft Word and Excel.

Requirements

• University Degree preferred (Life Science desirable).
• 1-3 years of relevant experience.
• Knowledge of working within a highly regulated industry or experience in CRO/Pharmaceutical Company industry.

Benefits

• Equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.