Clinical Technology Lead

Role Summary

The Clinical Technology Lead is responsible for the strategic implementation of clinical data systems across the portfolio, working with leadership to align protocol needs with industry best practice, innovative solutions and client standards. They will take an active role in 3rd party management and governance and support strategic processes and relationships as client builds and expands its technology suite and data infrastructure.

onsite in Radnor, PA 4 days/week

• Lead as point contact for clinical data systems utilized within the client portfolio, working closely with the client team and 3rd party vendors to provide subject matter expertise throughout the SDLC
• Review and provide input on critical documentation for system delivery, inclusive of internal documents (i.e. client protocol) and external documents (i.e. 3rd party system design specifications)
• Manage overall system implementation at a study level, ensuring the system is fit for purpose, supporting complex clinical trial events and protocol requirements
• Enforce client and industry best practice and standards, ensuring that "Quality by Design" (QbD) principles are embedded in the SDLC to minimize downstream system changes and data cleaning
• Collaborate with the 3rd party vendors to maintain governance for operational processes and teams that are balanced and efficient
• Lead the strategy for user acceptance testing
• Lead sustainability through cross functional training, collaboration and lessons learned
• Contribute to process development and improvement, as needed. May assist with upskilling and knowledge sharing for other team members.

• Bachelor’s degree in Life Sciences, Computer Science, or a related technical field (Advanced Degree preferred).
• Minimum 5 years of experience in clinical development with established knowledge of the clinical data systems, inclusive of eCOA, RTSM/IRT, eConsent and wearables
• Deep understanding of the clinical software development lifecycle (SDLC) and GCP/ICH regulatory requirements.
• Proficiency in global library management and standards development
• Significant experience in vendor oversight and project management, acting as lead contact for client
• Experience managing complex integrations and system administration is highly desirable.

• Technical Mindset:
  Ability to design scalable systems that serve the broader portfolio beyond a single study
• Leadership and Authority:
  Strong ability to influence and guide teams toward best practice and client standards.
• Strategic Thinking:
  Capable of identifying process improvements and innovative efficiencies
• Quality Focus:
  Commitment to building high-quality systems that prioritize "Critical to Quality" data elements.