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Job Description

Our client is seeking a skilled CSV Consultant to support their R&D team in a complex data integration initiative. This role will focus on validating and rearchitecting data connections from multiple CROs and internal systems into a centralized data lake, ensuring compliance with GxP standards and seamless integration with Veeva and Oracle Siebel CTMS platforms.

Key Responsibilities:

- Lead CSV activities for data migration and integration projects involving feeds from CROs and internal systems into CPS.

- Redesign and validate all system connections, ensuring robust data flow into a centralized data lake.

- Develop and execute test scripts to confirm system integrity and compliance.

- Collaborate with cross-functional teams in the US and Switzerland to align on validation strategy and timelines.

- Interface with Veeva and Oracle Siebel CTMS systems to ensure proper configuration and validation.

- Maintain documentation in accordance with GxP standards, with a focus on GcP and ideally GLP.

- Support audit readiness and ensure traceability of validation activities.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [email protected] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

Skills and Requirements

- 5+ years of experience in Computer System Validation (CSV) within a regulated R&D or clinical environment.

- Strong understanding of GxP principles, especially GcP; GLP experience is a plus.

- Hands-on experience with Veeva and Oracle Siebel CTMS systems.

- Proven track record in data integration, system connectivity, and validation scripting.

- Excellent communication skills and ability to work across global teams. - Experience working with CROs and managing external data feeds.

- Familiarity with data lake architecture and validation in cloud environments.

- Ability to work independently and manage multiple priorities in a fast-paced setting.