Sr. Manager, Clinical Trial Configuration

Role Summary

Sr. Manager, Clinical Trial Configuration leads the deployment of clinical technologies and business processes across the Clinical Data Systems (CDS) organization. You will own the system delivery life cycle in collaboration with Clinical Operations, DD&T, and Quality, establish technology standards and governance, and serve as the primary change agent to ensure adoption of new capabilities. You will work with study teams to enable efficient trial delivery and ensure inspection readiness. Location: Massachusetts – Virtual.

Responsibilities

• Leads in the deployment of technologies and business processes across the CDS organization.
• Establishment and support of business process SOPs.
• Accountable for the system delivery life cycle in collaboration with Clinical Operations, DD&T, and Quality organizations.
• Acts as a primary business change agent to ensure adoption of new capabilities and business processes.
• Leads with appropriate stakeholders to establish technology standards and governance models.
• Clinical Technology SME in Clinical Study Team accountable for the implementation of Clinical Technologies like eCOA, eConsent, Telehealth, Devices or licensing of COA instruments.
• Collaborates with leaders of supported business functions to identify and resolve issues impacting the delivery of clinical trials.
• Acts as a process expert for operational and oversight models.
• Participates in study-level technology vendor oversight activities.
• Other duties as assigned.

Qualifications

• Required: Minimum of 6 years drug development experience with direct clinical technology experience.
• Required: BS/BA in health-related, life science, or technology-related fields.
• Preferred: MS in health-related, life science, or technology-related fields.

Skills

• Clinical technology domain expertise (eCOA, eConsent, Telehealth, devices, COA instruments).
• Technology strategy, deployment planning, and governance.
• Stakeholder collaboration and vendor oversight at the study level.
• Change management and user adoption leadership.
• Operational and oversight process modeling and TMF/documentation readiness.
• Submission readiness support and audit/inspection representation for Clinical Trial Configuration (CTC) group.

Education

• BS/BA required or MS preferred in a health-related, life science area or technology-related fields.