Principal Clinical Database Designer

ob Overview

Lead and oversee a team of clinical database design professionals responsible for the delivery and build of multiple clinical studies across various platforms. Serve as a client-facing representative for the clinical database design function with accountability for project financials scope management and relationship development. Act as a Subject Matter Expert (SME) supporting IT teams on software application maintenance and adoption as needed.

Essential Functions

• Serve in a global SME role for clinical database design and data management.
• May act as a global librarian supporting and performing CAPA activities issue management and escalations.
• Perform project financial checks and reviews including budget monitoring and variance analysis.
• Define prioritize and manage resource requirements and assignments across projects.
• Implement departmental and office objectives; conduct peer reviews at a portfolio level.
• Provide expert review and guidance on Data Management deliverables including:
  • CRF/eCRF design
  • Database design and setup
  • Validation definition and programming
  • Data Management Plans
  • Database deliverables for internal and external customers
• Offer technical guidance and solutions to internal and external stakeholders to resolve issues and improve efficiency.
• Participate in the development and implementation of new processes and technologies.
• Ensure staff are trained and compliant with current SOPs work instructions and project scope. Identify and address professional development and training needs.
• Mentor team members to strengthen Data Management programming processes systems and drug development expertise.
• Provide design and programming input into proposals and scopes of work; may participate in proposal defenses.
• Lead or attend customer meetings to discuss project programming requirements and strategic planning.
• Maintain a thorough understanding of scope of work budgets and assumptions. Identify out-of-scope activities and prepare revised cost estimates with supporting documentation.
• Ensure project milestones are met according to agreed timelines and actively manage quality throughout the project lifecycle.
• Perform people management responsibilities including planning assigning and directing work.

Qualifications

• Bachelors degree in Science Computer Science Information Technology or Technology (required).
• 46 years of relevant core technical designer experience with 9 years of total professional experience (required).