Mexico City, MEX
3 days ago
TMF Analyst
**TMF Analyst role** **Full home based - Location: Mexico** Job Overview The **Trial Master File (TMF) Analyst** is responsible for management of sponsor TMF structure and records in the system and provides day to day operational support to the sponsor clinical trial teams on TMF structure management, TMF Quality review and inspection readiness. Essential Functions, includes but not limited to: • Responsible for management of expected TMF structure and records in the sponsor TMF Platform. • Able to create sponsor TMF platform (Veeva Vault) file plan for document requirement. • Maintenance of expected number of documents in sponsor eTMF by performing activities such as support in management of signposts, • Perform TMF quality and completeness review. • Support inspection readiness activities as needed. • Collaborate with the other teams/roles in sponsor organization for creating of training materials and job aids. • Support issue resolution in collaboration with other teams, identify gaps and escalate if required to follow up and close the identified gaps and issues. **QUALIFICATION** • Bachelor’s degree, preferably in a scientific discipline, is required. • Demonstrated proficiency with TMF Management. A minimum of 2 years of experience with eTMF system/platform • +2 years of experience with file reviews • Strong knowledge of eTMF platforms (Veeva Vault is preferred) • Understands the reports and complexity of study life cycle milestones in Veeva Set up, EDL management, tailoring. • Working knowledge of clinical research documents • Demonstrated current knowledge of ICH, GCP, and other regulatory guidance as applicable to management of clinical documentation • Advanced English level • Ability to work in an extremely fast-paced environment with changing priorities • Ability to work collaboratively and cross-functionally • Attention to detail and accuracy in work • Skilled in verbal and written communication skills • Experience in Microsoft Office suite. Competency in Microsoft Excel is added advantage. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us. EEO Minorities/Females/Protected Veterans/Disabled
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