AI-Driven Clinical Capabilities Lead (eTMF)

Madrigal; Waltham (MA); On-site; USD 172,000 - 210,000; Full time

Benefits offered by this job

Equity

Bonus

401(k) plan

Medical, dental, vision

Paid time off

Mental health benefits

Job summary

Madrigal is seeking a Clinical Capabilities Innovation Lead to design, launch, and optimize AI-enabled clinical operations capabilities, focusing on the eTMF ecosystem. You will collaborate with Clinical Operations, TMF Operations, Quality, and IT to deliver scalable, compliant solutions and drive efficiency.

You will lead system design for AI-enabled operating models, support Veeva Vault configurations and releases, and ensure inspection readiness with a strong emphasis on data integrity and

Qualifications

• Bachelor’s degree required; life sciences, health sciences, information systems, or related field preferred.
• 10–12 years total experience and 8–10 years in progressive clinical operations systems roles in biotech/pharma.
• Experience in clinical operations, clinical systems, eTMF operations, or related clinical development functions.
• Veeva Vault Administrator certification preferred.
• Experience with system integrations, data flows, APIs, automation, and AI-enabled processes.
• Ability to translate business needs into system requirements and practical solutions.
• Strong analytical, problem-solving, and stakeholder management skills.

Responsibilities

• Design and implement AI-enabled clinical operations capabilities within eTMF and related systems.
• Partner with IT, QA, and vendors to ensure compliance, validation, and inspection readiness.
• Lead lifecycle support for Veeva Vault deployments and system releases.
• Analyze system updates and prioritize enhancements with IT teams.
• Monitor process performance, quality trends, and user adoption for continuous improvement.
• Build cross-functional relationships with Clinical Operations, IT, and Quality.

Skills

Clinical operations systems

Veeva Vault Clinical applications

APIs and data integrations

AI-enabled process design

Quality and regulatory compliance

Education

Bachelor's degree in life sciences, health sciences, information systems, or related field

Tools

Veeva Vault

APIs

Job description

Madrigal is seeking a Clinical Capabilities Innovation Lead to design, launch, and optimize AI-enabled clinical operations capabilities, focusing on the eTMF ecosystem. You will collaborate with Clinical Operations, TMF Operations, Quality, and IT to deliver scalable, compliant solutions and drive efficiency.

You will lead system design for AI-enabled operating models, support Veeva Vault configurations and releases, and ensure inspection readiness with a strong emphasis on data integrity and