Clinical Systems Leader

About This Role

This role involves implementing and managing clinical systems for early clinical development, ensuring successful technology solutions for clinical trials. The Clinical Systems Leader collaborates with internal stakeholders and technology vendors to ensure proper system implementation and adherence to industry regulations.

Responsibilities

• Implement clinical systems like Interactive Response Technologies (IxRS) and electronic Clinical Outcome Assessments (eCOA) for the ECD portfolio
• Manage study-related timelines and activities, leading end-to-end specifications for clinical system builds
• Provide technical oversight to ensure clinical systems adhere to protocol, regulations, and company policies
• Work collaboratively with cross-functional internal stakeholders and technology vendors
• Proactively identify, track, and resolve study-level technical issues and implement mitigation plans
• Communicate technical issues clearly and professionally with stakeholders and leadership

Requirements

• 2-5 years of experience in Clinical Operations, or Clinical Systems Management
• 2-5 years of IxRS/IRT and clinical-related systems experience
• Successful track record in leading the implementation of clinical systems (IxRS/IRT, ePRO, eCOA)
• Working knowledge of Good Clinical Practices and FDA regulations
• Excellent written and verbal communication skills
• Strong project management skills
• Familiar with documentation in a regulated environment

Qualifications

• Bachelor's Degree in life science, computer science, engineering, information system, data science or related discipline
• 2-5 years of experience in Clinical Operations, Clinical Systems Management, and IxRS/IRT and clinical-related systems

Nice to Have

• Experience in Veeva

Skills

* Required skills