• Works closely with Manager and Clinical Operations personnel to perform quality checks and file Clinical Trial Master File (TMF) to ensure high quality documentation in accordance with country-specific regulations, ICH Guidelines, Good Clinical Practices (GCPs), and Takeda’s Standard Operating Procedures (SOPs) and Business Practices.
• Provides centralized support for document upload and data entry in operational and document management systems (e.g., CTMS, clinical trial and budget tracking, electronic Trial Master File (eTMF), electronic document management system (EDMS) etc.)
Duties and Responsibilities:
• Conducts quality checks of the Clinical TMF documents.
• Work with internal functional area document owners and CRO to remediate any issues identified with Clinical TMF documents during quality check.
• Scans, files and maintains study documentation in the Clinical Trial Master Files and in the electronic Trial Master Files system and/or applicable Records Management system.
• Provides central support for uploading clinical TMF documents to EDMS to support key trial activities (e.g., regulatory submissions, clinical study reports etc.).
• Work with GDO stakeholders to review and manage operational clinical trial data to ensure quality and completeness per data quality standards and specified system guidelines.
• Provide centralized data entry support for operational systems ensuring alignment with data quality standards.
• Review and contribute to processes and tools in support of maintaining operational and document management systems to ensure quality and completeness.
• Review operational data to inform and document trends and risk areas to key stakeholders
• Support other trial related operational activities as needed and assigned.
- BA/BS with 1-3 years of industry or comparable experience; candidates with some clinical research educational courses and knowledge of regulatory and Good Clinical Practice requirements preferred; understanding of the Trial Master File including understanding of the DIA TMF Reference Model preferred; experience working in electronic Trial Master File specifically Veeva Vault eTMF platform preferred; internal candidates must have demonstrated high performance in current position
- • Strong attention to details
- • Strong interpersonal and communications skills
- • Strong organizational skills and techniques
- • Proven initiative and work ethic
- • Comfort working with data and data entry
- • Tolerance of ambiguity and willingness to work through complex issues
- • Ability to work with various Takeda stakeholders to achieve desired goals
- • Proficiency with MS Office Applications, SharePoint, Visio, et