TRI supports many Federal and private sector clients in investigational research and development. The Veeva Regulatory System Administrator serves as the primary regulatory Software-as-a-Service (SaaS) resource providing technical services and subject matter expertise for TRI's Clinical Operations, Regulatory, and IT staff.
Responsibilities center on system administration, development, and business services including:
- Direct administration of the Veeva Regulatory and Clinical SaaS platforms creating and managing object records, templates, content plans, and mastered data elements (e.g. List of Values) for TRI client research.
- Access management through administration of users, groups, and security roles including external access.
- System and client configuration through establishing document types, fields, lifecycles, as well as, supporting automation through workflows and notification management. Example duties may include: configuring cascading review and approval flows for submission binders or template.
- Supporting Clinical and Regulatory users managing regulatory binders, submissions, and electronic Trial Master Files (eTMFs) with direct assistance troubleshooting and improving document management within the SaaS system. Example duties may include: configuration of expected documents and milestones in the eTMF; creating blinded and unblinded content; bulk document transfers (e.g. via VaultLoader) or creating records in bulk; creating views and customized workflows for document and submission approvals, etc.
- Evaluating, planning, and managing direct integrations with related systems including standard vault to vault connections between TRI's Clinical Operations eTMF vault and a RIM Submissions vaults as well as external integrations with Medidata CTMS, EXTEDO or Lorenz eCTD submission tools, or bespoke SharePoint or .NET platforms with support from TRI IT developer staff.
- Evaluating advanced system features for TRI and client research including Vault Mobile access, eConsent strategies and emerging regulatory technologies as directed.
- Providing input and content to business development teams in support of new proposals or marketing collateral.
- Bachelors Degree in Computer Science, Public Health, Clinical Research, Clinical Research Administration, or similar health- related technical field.
- Solid understanding of clinical research relating to operations (especially site essential document collection and sponsor trial master file requirements) and regulatory services (especially IND study submissions planning for FDA, EMA, and other regulatory authorities).
- Knowledge of Veeva's system objects and architecture, including the Advanced Data Model describing metadata and relationships between objects (e.g., documents, studies, dossiers, etc). Significant experience in other commercial leading eTMF and Regulatory Information Management platforms may be considered, but Veeva is strongly preferred.
- Functional database query/SQL skills required for evaluating upstream or downstream document repositories.
- Working knowledge of XML to assist in developing/troubleshooting IND submissions and data exchanges.
- Advanced technical expertise with common business applications used in regulated clinical documents. including Microsoft Word, Excel and Adobe PDF. Ability to troubleshoot document versioning, security, or formatting issues as they arise.
- Facility with planning and executing data transfers to and from regulated systems; capturing documents and creating/processing associated Excel/CSV/datasets with the metadata required for each document.
- Veeva Certification (minimum White Belt) preferred.
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