Sr. Clinical Trial Manager
About the position At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference. When you join Genetix, you're not just landing a new role, you become part of a company that's pursuing curative gene therapies to give patients and their families more days. We are doers, thinkers and collaborators who embrace and live by our values: Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care. SUMMARY The Senior Trial Manager in Clinical Trial Strategy & Execution (CTSE) is a member of the Clinical Development Operation functional team. CTSE is an integrated and diverse team that advances and optimizes the strategic design, development and execution of bluebird bio’s clinical research studies program (Long-Term Follow-up, Phase III & Phase IV studies). We are committed to operational excellence and inspired by the patients and families who participate in our programs. This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.
Responsibilities
- Responsible for assigned clinical trials being managed to the highest
- Responsible for all aspects of study planning and execution (in support of Regulatory filings), such as timelines, budget, team management, and vendor oversight, with a focus on inspection Oversee financial aspects of the study.
- Accountable for the performance and delivery of all trial activities, including oversight and management of complex, cross-functional study level issues. Value, promote and recognize performance achieved through teamwork and Presents work to cross-functional groups/ committees when requested.
- Makes study level decisions and drives difficult team or vendor discussions to resolution, understanding when to pull in relevant stakeholders.
- Lead cross-functional teams or workstreams with a meaningful impact on critical Point of escalation for study teams: Works with cross-functional partners and vendors to discuss issues, develop solutions, follow through resolution, and implement process improvements. Proactively communicates complex and sensitive study information or issues and understands stakeholder impact. Independently navigates complex issues that hold major impact on the program.
- Lead and own formal risk assessment activities, contingency planning, escalation, and approve corrective action plans. Oversee and assist the CRA team when issues arise or deliverables are at risk.
- Execute data Review study data, communicate study status, risks, and issues effectively both internally and with outsourced partners
Requirements
- 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.
- 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.
- Proven compliance with FDA & EU regulations, ICH/GCP, experience working in other
- Strong verbal and written communication
Nice-to-haves
- Experience in managing Phase IV studies preferred but not required.
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