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Senior Associate I, TMF Operations
Worldwide Clinical TrialsSenior Associate I supporting TMF Operations handling document processing and compliance. Collaborating with global project teams and providing expert support for clinical studies in a remote capacity.
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- Health insurance
- Professional development opportunities
- Flexible working hours
- Remote work options
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
TMF managementQC process oversightKPI reviewmetrics preparationdata analysis
Soft Skills
written communicationverbal communicationinterpersonal skillsorganizational skillsplanning skillsattention to detail