About this role TFS HealthScience is a leading global
mid-size Contract Research Organization (CRO) that partners with
biotechnology and pharmaceutical companies throughout their entire
clinical development journey. Our expertise includes full-service
capabilities, resourcing, and Functional Service (FSP) solutions.
The Veeva Vault Subject Matter Expert (SME) for Regulated
Activities (Investigator Initiates Studies, External Collaborative
Research, Early Access Treatments, Observational and
Non-interventional Studies) will provide general OMP Services to
platform end-users by combining hands-on operational support with
expert guidance on the system and process. The OMP SME will become
the first point of contact to other OMP squad members, ensuring
compliant, consistent and high-quality use of OMP. Key
Responsibilities Tracking studies in Veeva Clinical o Manage the
creation of new studies and projects in Veeva Vault in accordance
with internal processes and standards. Coordinate with stakeholders
to ensure complete and compliant setup of studies/projects in Veeva
Vault.
o Maintain study/project data up to date, following internal
guidelines and process requirements. Ensure timely and accurate
data entry across all relevant fields and systems. Proactively
follow up with stakeholders to retrieve missing or incomplete
information. Generate system reports and document status summaries
upon request. Filing documents in Veeva Clinical and Veeva RIM.
Prepare and share metrics reports and participate in meetings with
Regulated Activities Service Coordinator and other stakeholders.
Support OMP squad understanding and adherence to the OMP How to
Guides (HTG). Support the enhancement and production of OMP HTGs
and other OMP related guidance documentation (naming conventions,
training ppts etc.). Active participation in regular calls with
corporate OMP responsible to escalate issues and questions from the
OMP Squad. Document and keep track of OMP most frequently asked
questions