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Senior Clinical Document Manager
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The clinical trials landscape is characterized by rigorous regulatory requirements and the need for meticulous document management. As a Clinical Document Management Professional, you will be responsible for overseeing and managing Trial Master Files (TMFs) for assigned clinical trials, ensuring compliance with ICH-GCP standards and internal processes.
Key Responsibilities:- Establish and oversee the setup of clinical TMFs for assigned studies, guaranteeing seamless integration with existing systems.
- Maintain high-quality clinical department trial master files at all times, capable of passing audits without issue.
- Lead interactive TMF kick-off meetings with cross-functional teams and CROs to ensure effective collaboration and project understanding.
- Develop, maintain, and update comprehensive TMF Plans throughout the study lifecycle, catering to evolving project needs.
- Monitor and analyze TMF quality and completeness, providing actionable metrics, reports, and remediation plans as required.
- Offer guidance and oversight to junior team members, including Associate TMF Managers and Clinical Documentation Administrators.
- Act as the primary point of contact for TMF contributors, providing expert knowledge on TMF processes and eTMF/EDMS systems.
- Coordinate proactive TMF readiness for audits and inspections, ensuring timely document provision and thorough compliance checks.
- Facilitate in-depth TMF reviews, corrective action planning, and secure final archiving of TMFs, adhering to industry best practices.
- Provide training and mentorship to newcomers on advanced TMF processes and tools, promoting skill development and retention.
- Contribute to innovative digital initiatives and process improvements within clinical document management, driving efficiency and excellence.
This role requires an individual with exceptional clinical documentation expertise, outstanding organizational skills, and the ability to collaborate effectively across diverse teams.
