• Provide day to day document management support to Clinical Operations, Clinical Research, Data Management, Medical Writing, Statistics and Statistical Programming, Clinical Supply Chain, Regulatory and Safety and be an initial point of contact for Trial Master File (TMF) process related questions• Ensure standard service level agreements are maintained• Ensure adherence to Standard Operating Procedures, Good Clinical Practice, Good Documentation Practices, International Council for Harmonization E6(R2), and ALCOA+ standards• Author, contribute to, maintain and implement TMF Management Controlled Documents and associated resources (e.g. training materials, knowledge databases)• Administer on-site training, across Clinical Development, on the policies and procedures relative to and for document quality and process• Perform and manage ad hoc TMF Quality Assessments• Lead appropriate Clinical Development document-related Regulatory Inspection Readiness Activity• Act as a system of record (i.e. eTMF) expert and an initial point of contact for system related questions• Play a pivotal role in the generation, interpretation, cascade and escalation of metrics for the TMF• Work with Contract Research Organization (CRO) partners and Third-Party Clinical Vendors on the continued development of TMF and Record Management practices and expectations

- Test plans, risk assessments, validation summaries and test scripts creation- Test scripts execution- Bug reporting in Jira- System validation supervision- Interdepartmental cooperation- 2nd Line Support tasks