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 global 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 and issues.

• Organize and lead global stakeholder trainings on OMP (for Regulated Activities only) in collaboration with Regulated Activities Coordinator.

• Serve as the single point of contact for OMP-related questions within Regulated Activities.

• Review quality of squad work.

Qualifications

• Bachelor's degree in science related careers (pharmacy, biology, chemistry, data science, among others).

• Technical proficiency with Veeva Vault system, with focus on Veeva Clinical and Veeva RIM.

• Familiar with the regulated environment (GxP).

• English fluent in written, reading, speaking - work will be 100% in English.

• Strong organizational skills, service-oriented, and attention to detail.

• Good communication skills.

• Ability to multi-task and function under high pressure environments.

• Proactive attitude and willingness to learn in a collaborative environment.

What We Offer

We provide opportunities for personal and professional growth in a rewarding environment. You will join a team that values collaboration, quality, and making a difference in the lives of patients.

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability guide our decisions and shape our culture. By aligning on these values, we foster collaboration, innovation, and a shared commitment to excellence. Together, we make a difference.

A Bit More About Us

Our journey began over 30 years ago in Sweden, in the city of Lund. As a full-service global CRO, we build solution-driven teams working toward a healthier future. Bringing together over 600 professionals, TFS delivers tailored clinical research services in more than 50 countries, offering flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.