Related skills
lms smartsheet ms project etmf ctms📋 Description
- Provide SME guidance on clinical system operations across study teams and vendors.
- Lead end-to-end clinical system programs: scope, planning, timelines, resources, execution.
- Manage insourced/outsourced clinical system projects: IRT, site portals, CTMS, eCOA.
- Establish governance: risk, issues, dependencies, executive status reporting.
- Collaborate with IT, QA, and Clinical System Validation teams for implementation and lifecycle.
- Ensure compliance with SOPs, GDocP, ALCOA-CCEA and GCP; manage changes.
🎯 Requirements
- Bachelor’s degree or higher or equivalent experience.
- 10+ years managing clinical system activities in biotech/pharma.
- Experience implementing eCOA, IRT, eTMF, CTMS, and LMS.
- Veeva Vault experience preferred.
- Experience with validation, SOPs, and integration of clinical systems.
- PM methodologies (Agile/Waterfall/hybrid) and PM tools (Smartsheet, MS Project).
🎁 Benefits
- Culture rooted in the CORE values: Caring, Original, Resilient, Egoless.
- Fast-paced environment shaping culture and career growth.
- Competitive compensation: base, bonus, equity, benefits.
- Generous PTO, company-wide shutdowns, dedicated sick leave.
- Professional development opportunities.
- Regular all-team in-person meetings to build relationships.
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