Senior Clinical Trial Manager

bluebird bio

full-time

Posted on: 9/3/2025

Origin: • 🇺🇸 United States • Massachusetts

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Senior

Google Cloud Platform

About the role

Oversee all aspects of clinical study management for a gene therapy product; manage one or more complex studies with minimal supervision.
Plan and execute studies in support of regulatory filings: timelines, budget, team management, vendor oversight; oversee financial aspects and inspection readiness.
Accountable for performance and delivery of all trial activities; manage complex cross-functional study-level issues and present to cross-functional groups/committees.
Make study-level decisions, drive difficult team/vendor discussions to resolution, and manage competing priorities.
Lead cross-functional teams or workstreams; act as point of escalation with partners and vendors and communicate complex/sensitive study information.
Lead risk assessment, contingency planning, escalation, and approve corrective action plans; assist CRA team when deliverables are at risk.
Review study data, communicate study status, risks, and issues internally and with outsourced partners.
Implement new processes and procedures per SOPs and regulations/guidance.
Serve as Clinical Subject Matter Expert for internal/external audits and agency interactions; prioritize relationship management with investigators, staff, and vendors.
May present at external conferences; contribute to study publications; domestic and international travel may be required.

Bachelor’s degree in a life science
Minimum 7 years clinical experience (biopharma, CRO, healthcare), with at least 2 years of managing cross-functional project teams. Monitoring experience preferred.
Expert knowledge & breadth of expertise in all technical aspects of managing global clinical trials and overseeing cross-functional study teams with a proven track record.
Experience troubleshooting situations of non-
Proven ability to identify study priorities, key stakeholders, define goals, and drive/achieve results through a cross-functional study team. Connect study deliverables to a comprehensive timeline and budget.
Deep understanding of how study decisions, challenges, and achievements impact the overall
Proven compliance with FDA & EU regulations, ICH/GCP; experience with BLA submissions and regulatory agency inspections preferred.
Familiarity with clinical data review and data management processes, including Data Monitoring Committees
Strong verbal and written communication
Ability to work on teams with aggressive timelines and to multi-task in an extremely fast-paced and dynamic environment with changing priorities.
Independently motivated to learn and lead with minimal direction; detail oriented.
“Do-what-it-takes” approach to problem solving, creative and prospective thinking
Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view