Your new company

Your new role

Responsibilities:
• Sets up and maintains electronic Trial Master File (TMF) for multiple studies.
• Ensures that TMFs are always inspection-ready and assists with inspection preparation activities.
• Coordinates and/or conducts regular QC of TMFs and ensures findings are appropriately resolved.
• Acts as business administrator for eTMF and conducts user training.
• Reviews essential documents in support of site activation.
• Provides technical support to study teams by collating and organizing documents and data from multiple
sources.
• Accountable for study-level tracking (e.g., site activation, enrollment) as assigned by the team.
• Supports Study Management Teams by coordinating meetings, distributing agendas, and preparing clear,
organized, and accurate meeting minutes.
• May assist with financial activities (e.g., reviewing or reconciling invoices), as requested.
• Adheres to Good Clinical Practice and Standard Operating Procedures.
• Participates in department initiatives and development of department procedures.
Requirements:
Education and/or Experience:
• Bachelor’s degree in a relevant scientific discipline
• 2+ years of relevant Clinical Operations experience
• Solid experience with Trial Master File maintenance, including TMF Reference Model, TMF set-up, and TMF
QC activities
• Hands-on experience with Veeva Vault TMF is highly desirable.
Competencies and Attributes:
• Demonstrated ability to drive results that are needed to achieve company objectives
culture and values – courageous, imaginative, selfless and joyful.
• Demonstrated ability to manage multiple assignments; prioritizes work and problem-solves independently yet
understands when to involve others.
• Excellent interpersonal skills. Demonstrated ability to work as a team player.
• Strong communication skills, including active listening, verbal, and written communications skills.
• Strong attention to detail and excellent organization skills required.
• Proficient w/ Microsoft Office products (Excel, PowerPoint, Word).
• Understanding of Good Clinical Practice and application to assignments

What you'll need to succeed

What you'll get in return

What you need to do now

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.

If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion on your career.

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