Sr. Manager, Clinical Trial Configuration

Role Summary

Sr. Manager, Clinical Trial Configuration is responsible for leading the deployment of clinical technologies and related business processes across the CDS organization. This role ensures the end-to-end system delivery lifecycle, establishes and supports SOPs, and acts as a primary change agent to drive adoption of new capabilities and processes. You will collaborate with Clinical Operations, DD&T, Quality, and other stakeholders to establish technology standards and governance models; serve as the Clinical Technology SME for study teams; and coordinate study-level technology vendor oversight and inspection readiness. Location: Massachusetts - Virtual.

Responsibilities

• Lead the deployment of technologies and business processes across the CDS organization; establish and support business process SOPs.
• Accountable for the system delivery lifecycle in collaboration with Clinical Operations, DD&T, and Quality.
• Act as the primary business change agent to ensure adoption of new capabilities and business processes; establish technology standards and governance models with stakeholders.
• Serve as the first point of contact for the implementation of Clinical Technologies (eCOA, eConsent, Telehealth, devices) or licensing of COA instruments.
• Collaborate with leaders of supported business functions to identify and resolve issues impacting the delivery of clinical trials; act as a process expert for operational and oversight models.
• Participate in study-level technology vendor oversight activities; confirm archival and inspection readiness of Clinical Technology TMF documents; participate in submission readiness and representation of the Clinical Trial Configuration group in inspections or audits.
• Follow designated strategy for study-level technology deployment and vendor oversight; perform other duties as assigned.

Qualifications

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

Skills

• Clinical technology subject-matter expertise across eCOA, eConsent, Telehealth, devices, and COA licensing processes.
• Ability to develop and execute technology selection and deployment strategies across Clinical Studies in alignment with SOPs, policies, and governance models.
• Experience serving as a primary business change agent to drive adoption of new capabilities and processes; coordinate with Clinical Technology vendors to meet milestones and deliverables with high quality.
• Strong collaboration with leaders of supported functions to identify and resolve issues impacting clinical trial delivery; provide process expertise for operational and oversight models.
• Knowledge of archival and inspection readiness for TMF documents and involvement in submission readiness activities and audits.

Education

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