Trial Master File Associate
il y a 1 semaine
**Location: Cork, Ireland (funded relocation package 2000 EUR + 2 weeks paid accommodation) + great benefits and salary**
**Req: EU Passport**
The Associate role - TMF Projects is part of the Trial Master File Project Team in Cork and is a key partner across Clinical Capabilities which serves as a key role for the execution of TMF Operations processes and administration. Provides process support for TMF creation, maintenance, closure, and archival.
**TMF Expertise**
- Partner with internal colleagues to develop and execute metrics to demonstrate control of the TMF process.
- Support internal audits and external inspections
- Assists TMF Process Specialist with providing process and planning support to study teams with TMF-related remediation and process execution as needed.
- Handles eTMF process-related questions and answers.
- Provide support with TMF Operations administrative activities such as TMF open office hours, meetings agendas/minutes, etc.
- Provide support to ongoing and ad-hoc TMF projects and initiatives.
2**. Project Management**
- Define, manage, and execute TMF implementation plans for the trial from start-up to close-out.
- Communicate global internal/external requirements
- Provide support with TMF Operations administrative
3. **Partnership**
- Collaborate and influence functional representatives and record owners to ensure TMF remains complete, current and correct.
- Identify opportunities to share learning to the functions as appropriate.
- Assists with TMF process education efforts.
- Support integration of partnered or acquired clinical information including transfer of TMFs in compliance with applicable regulations and best practices.
- Assist with eTMF configuration testing, as needed.
4. **Clinical Trial Essential Document Responsibilities**
- Evaluate the TMF records prior to finalization, as appropriate.
- Communicate directly with functional areas for proper hands-off to occur during the start-up, maintenance and close-out of the trial.
- Identify, communicate, and resolve issues.
- Ensure appropriate functional check oversight activities occur for all functional areas.
- Ensure appropriate archiving of clinical trial documents to meet the company record retention policies and regulatory requirements.
- Understand, comply, and reinforce local regulations and guidance, medical policies and procedures, and good clinical practices (GCP)
- Ensure inspection readiness through a complete, accurate, and readily available Trial Master File
Minimum Qualification Requirements:
- 1-2 years of experience with clinical development processes
- Bachelor’s degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or drug development is desirable
- Experience in document administration
- Knowledge of cGCP
- High attention to detail
- Excellent organizational skills
- Strong written and verbal communication skills; and Proficiency with MS Office/Adobe Acrobat
- Experience in working with electronic trial master files strongly **preferred**
**Job Types**: Full-time, Permanent
**Salary**: 35,000.00€ - 55,000.00€ per year
Ability to commute/relocate:
- Paris (75): Reliably commute or planning to relocate before starting work (required)
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