The eTMF Specialist assists with adoption and onboarding of all functions and 3rd party vendors for both eTMF system and processes. Provides ongoing support focusing on effective use of process, working closely with clinical operations teams and other functional areas.
ESSENTIAL JOB FUNCTIONS:
In collaboration with clinical operations teams and functional areas outside of Global Development Operations (GDO), manages study-specific Trial Master Files (TMF), both electronic (eTMF) and paper in format.
Supports Study Team eTMF Oversight, and reviews eTMF Plan and eTMF Master Index.
Attends study specific meetings to report on eTMF metrics with highlighted improvements/concerns, CRO/QC activities/findings/status of remediation, and Summary of query/missing document trends.
Develops processes and tools to support the performance of eTMF QC activities, escalating issues as necessary to Study Leads and CRO management.
Act as Inspection Readiness & Mock Audit core team member.
Handles the Set-up process for granting direct inspector access to eTMF during inspections and ensures rapid retrieval of documents during regulatory inspections.
Ensures eTMF structures comply with regulatory guidance and Xeris’ internal standards.
Provides input on the revision of eTMF-related Standard Operation Procedures (SOPs), work instructions , and internal eTMF-related tools.
Assists in the creation, maintenance and archival of eTMF in accordance with SOPs, GCP, and FDA regulations.
Develops eTMF knowledge with progression toward subject matter expert for eTMF systems.
Must have High School Degree or GED
Must have Veeva Vault eTMF experience
Minimum of 3 years industry experience in supporting the operations of clinical studies, including duties related to records management and maintenance of TMF/eTMF
Good working knowledge of FDA, MHRA, and ICH GCP regulations, guidelines, and standards governing regulated clinical research, essential documentation, and good documentation practices
Thorough knowledge of the DIA TMF reference model is preferred.
Internal Number: 2019-1086
About Xeris Pharmaceuticals
Xeris is a specialty pharmaceutical company leveraging its novel technology technology platforms to develop and commercialize ready-to-use, room-temperature stable injectable and infusible drug formulations. The company’s proprietary XeriSol™ and XeriJect™ formulation technologies are being evaluated for the subcutaneous (SC) and intramuscular (IM) delivery of highly-concentrated, non-aqueous, ready-to-use formulations of peptides, small molecules, proteins, and antibodies using commercially available syringes, auto-injectors, multi-dose pens, and infusion pumps. XeriSol™ and XeriJect™ have the potential to offer distinct advantages over existing formulations of marketed and development-stage products, including eliminating the need for reconstitution, enabling long-term room-temperature stability, significantly reducing injection volume, and eliminating the requirement for intravenous (IV) infusion. These attributes may lead to products that are easier to use by patients, caregivers, and health practitioners and reduce costs for payers and the healthcare system.