Role Summary:
Provide leadership and deep subject matter expertise in drug development processes, including change management and support activities for the Clinical Data & Information Sciences / Clinical Development & Operations (CD&O) system portfolio. Partner with Digital & Technology and CDO to ensure timely system data integrity and compliance.
Responsibilities:
- Facilitate integration of 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 for scalable solutions
- Ensure critical information/records in CD&O-owned repositories are managed per external regulations and internal processes; protected and controlled long term; retained per schedules
- Implement infrastructure update improvements to enhance end-user experience
- Participate in governance, change management, roadmap, and budget planning for the application portfolio
- Lead CDO Clinical Data & Information Sciences teams; liaise with business/technical groups to gather requirements and define or improve business/support processes
- Provide solutions to complex operational issues and influence stakeholders to reach decisions
- Coordinate system release activities
- Interface with strategic projects and service vendors to influence direction, usability, features, and performance
- Proactively engage partner groups to explore new technology solutions
- Lead/facilitate solution test strategies and user acceptance testing during releases to ensure high-quality systems
- Serve as subject matter expert/content interface for regulators; provide inspection readiness consultation and in-room support during inspections/audits
Basic Qualifications:
- Bachelorโs (8+ years) or MBA/MS (7+ years) or PhD/JD (5+ years) or MD/DVM (4+ years)
- Knowledge of healthcare/pharma drug development environment and regulations
- Understanding of clinical trial processes (study startup, site management/monitoring, operational reporting)
- Strong customer relationship skills, cross-functional collaboration, and verbal/written communication/presentation
- Ability to interface with international colleagues and understand system/process implications
- Strong project management/organizational skills; analytical/problem-solving/planning; ability to evaluate data quality and applications; customer-oriented approach
Preferred Qualifications:
- Masterโs with relevant pharma industry experience
- Experience leading cross-functional teams and large-scale projects
- Advanced Veeva Clinical or other CTMS knowledge
- Strong understanding of regulatory requirements/compliance
- Track record driving digital transformation
- Ability to manage multiple priorities in fast-paced environments; strong leadership/team management
- Experience using AI tools (e.g., ChatGPT, Microsoft Copilot) for problem solving
Non-Standard Requirements:
- Operations-focused; may require unplanned night/weekend work
Application Instructions:
- Last date to apply: June 10, 2026
- Hybrid: live within commuting distance; on-site ~2.5 days/week