Related skills
ms office smartsheet edc etmf ctms📋 Description
- Act as central contact for cross-functional study team communications and documentation
- Maintain and QC study Master Files (TMF/eTMF) for inspection readiness
- Track and report study metrics across start-up, data management, and contracting
- Participate in GxP audits and related clinical compliance activities
- Prepare and track study documents (contracts, budgets, IRB docs)
- Maintain systems (EDC, eTMF, CTMS, Payments) and ensure QA readiness
🎯 Requirements
- BS/BA in Life Sciences or equivalent
- 4+ years in biotech/pharma/CRO in an R&D role
- TMF setup/maintenance, QC/QR, query management; DIA model familiarity
- Knowledge of ICH/GCP and applicable regulations
- Strong written, verbal, and interpersonal communication
- Proficient in MS Office, SmartSheet, and ISI Toolbox
- Travel up to 15-20%, including in-person All Hands meetings
🎁 Benefits
- Culture centered on C.O.R.E. values: Caring, Original, Resilient, Egoless
- Fast-paced, dynamic environment with growth opportunities
- Competitive compensation plus bonus and equity options
- Health, welfare, and retirement benefits
- Generous PTO, company-wide shutdowns, and sick leave
- Professional development resources and training
Meet JobCopilot: Your Personal AI Job Hunter
Automatically Apply to Operations Jobs. Just set your
preferences and Job Copilot will do the rest — finding, filtering, and applying while you focus on what matters.
Help us maintain the quality of jobs posted on Empllo!
Is this position not a remote job?
Let us know!