Role Summary / Responsibilities:
- Provide leadership and subject matter expertise in drug development processes, change management, and support for the Clinical Data & Information Sciences / Clinical Development & Operations system portfolio.
- Partner with Digital & Technology and CDO functional lines to ensure timely data integrity and compliance.
- Integrate Clinical Data & Information Sciences solutions into business processes.
- Define strategies, best practices, and sustainable solutions to ensure quality of content management systems.
- Lead continuous improvement of scalable solutions.
- Ensure CD&O-owned repository records/content are managed per regulations and internal processes; protected and controlled long term; available for critical needs; retained per schedules.
- Implement infrastructure updates to enhance end-user experience.
- Participate in governance, change management, roadmap, and budget planning for the application portfolio.
- Lead teams and liaise with business/technical groups to gather requirements and define/improve processes.
- Resolve complex operational issues and communicate solutions to drive decisions.
- Coordinate system release activities; interface with vendors to influence direction, usability, features, and performance.
- Lead solution testing strategy and UAT approaches during releases.
- Serve as SME/content interface for regulators; provide inspection readiness consultation and in-room support during inspections/audits.
Qualifications:
- Bachelorโs +8 years OR MBA/MS +7 OR PhD/JD +5 OR MD/DVM +4.
- Knowledge of healthcare/pharmaceutical drug development regulations and clinical trial processes (startup, site management/monitoring, operational reporting).
- Cross-functional collaboration; strong communication/presentation; international stakeholder interface.
- Strong project management, analytical/problem-solving/planning, data quality evaluation, and relationship management/influencing skills.
Preferred:
- Masterโs with relevant pharma experience.
- Experience leading cross-functional teams/large-scale projects.
- Advanced Veeva Clinical or other CTMS knowledge.
- Strong pharma regulatory/compliance understanding; digital transformation track record.
- Ability to manage multiple priorities in fast-paced environment; leadership/team management.
- Experience with AI tools (e.g., ChatGPT, Microsoft Copilot).
Application Instructions:
- Last date to apply: June 10, 2026.