Vertex Pharmaceuticals is in a transformational period where they are accelerating their capabilities, technologies, and data to augment their scientific mission, enable growth, and remain at the forefront of science, medicine, and technology. It is critical that users have data "at their fingertips" with a strong platform team to build and enable additional value. The Associate Director | Clinical Data Platform will be responsible for leading and managing the delivery & operations team that manage and enable Vertex’s Clinical Data Standards & Electronic Data Capture (EDC) solutions enterprise wide.
Requirements
- Successful track record working with Clinical Data Platforms & Clinical Trial Data
- Demonstrated experience working with GxP solutions in the Clinical Trials environment
- An understanding of enterprise software development tools and methodologies
- Strong understanding of FDA, ICH, & CDISC regulations and industry standards
- Strong understanding of Clinical platforms including Veeva CDMS, and Elluminate and the management of a technology ecosystem
- High level of comfort sourcing, manipulating, and visualizing clinical data and providing contextualized data to business teams
- Demonstrated understanding and experience with authoring, developing, and maintaining SOPs for Clinical applications
Responsibilities
- Estimate, architect, and execute on the delivery of critical clinical data solutions across the enterprise in partnership with the DSE leadership team
- Lead a comprehensive, global team of engineers and consultant teams to deliver value and manage Vertex’s CDSP and EDC technologies
- Own, operate, and manage GCP data and analytics solutions in alignment with SOPs and industry best practices
- Advocate for automation, security, compliance and standards across the Clinical Data Management space
- Advocate for process enhancements and opportunities to improve our data & analytics capabilities with a focus on modern data engineering capabilities and approaches
- Engage with IT teams to improve our existing data solutions and drive increased value with our Clinical Data Standards Platform (CDSP) and our EDC capabilities
- Work in partnership with the Director | Data Platforms to architect sound solutions, secure data, deliver continuous value, standardize our solutions, and advance our data platform
Other
- Lead and mentor a high performing team of employees and contractors to deliver predictable value with quality and agility
- Partner with and enable the Clinical Data Management, Quality, Regulatory, & Study execution teams to deliver on prioritized outcomes
- Experience in delivery in agile environments (5+ years)
- Demonstrated ability to work independently and manage multiple projects that require collaboration across clinical areas
- Skillful, collaborative team player able to develop rapport and credibility with stakeholders
