Axtria is seeking a Project Lead with strong expertise in Application Release Management across Life Sciences and Clinical Drug Development systems including EDC, CTMS, RTSM, RCM , eTMF from vendors such as Medidata and Veeva. The Release Manager will oversee and coordinate end to end release activities for clinical data systems, ensuring timely, compliant, and high quality deployments. The role requires strong release planning, stakeholder management, GxP compliance knowledge, and hands on experience with cloud based clinical application suites and EDC ecosystems. Experience supporting Managed Services for Clinical R&D platforms is preferred.
- Develop and manage clinical applicat ions ( e.g., EDC , CTMS, RTSM, RCM, eTMF) release schedules, ensuring all stakeholders are aligned on timelines and deliverables.
- Coordinate with SaaS vendors, their product release teams and support desks , to plan for upcoming release s, understand i mpact, and resolve issues .
- Coordinate with QA teams to ensure comprehensive testing, addressing defects proactively before deployment.
- Implement structured change management processes to minimize disruption and ensure regulatory compliance.
- Maintain detailed release documentation including release notes, deployment plans, and rollback procedures.
- Collaborate with cross functional teams (business, technical, QA, vendors) to support smooth delivery handovers .
- Serve as primary contact for release related queries, maintaining strong relationships with business stakeholders.
- Conduct regular reviews with clients to assess satisfaction levels and identify improvement opportunities.
- Provide leadership to project teams, ensuring adherence to GxP and non GxP best practices.
- Demonstrate strong ownership and sense of urgency in completing release related responsibilities.
