Contract Clinical Trial Manager/Sr Clinical Trial Manager – Transfusion Dependent Thalassemia (6 Month Contract)
Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. Reporting to the Senior Director of Clinical Operations, the successful candidate will be responsible for all aspects of clinical trial management for our Phase 3 Transfusion Dependent Thalassemia (TDT) program. Responsibilities include study planning and execution, timelines, budget, with an emphasis on vendor management and oversight. You will also be responsible for the preparation of study related materials, relationship management between clinical sites and vendors, and identification of project risks and contingency planning. The ideal candidate must be comfortable working independently, managing interactions with and between clinical monitors, data management, biostatistics, medical writing, safety, regulatory affairs, and pharmaceutical science and QA team members, both internally and externally. Experience working on pivotal clinical studies in fast-paced and data driven environments with an emphasis on inspection readiness is a plus. Potential opportunity for conversion to a full-time employee.
About the role:
- Integral member of TDT Clinical Team working on two pivotal, global clinical studies and manage day-to-day operations
- Lead cross-functional internal/external study management meetings, working closely with your Clinical team members
- Manage to timelines and within budget (MS-Project experience a plus)
- Provide oversight and accountability of study vendors in a fully outsourced model
- Develop and ensure compliance with critical study documents including project plans, monitoring plans, study operations manuals, model informed consent form, IP traceability documents, etc.
- Execute on data deliverables (e.g., IB, DSUR) in support of ongoing studies
- Train team members and site staff, including vendors, as needed
- Perform clinical site activities, such as on-site monitoring, co-monitoring, training, and motivational visits, as needed
- Review and approve corrective action plans at individual sites and across study, active participant in internal/external study related audits
- Active engagement of KOLs and Study Investigators and staff, frequent communication with Medical Monitor
- Manage teams to meet goals across time zones and regions
- Work independently, escalate issues and reach out for support when needed
- BS/BA/RN Degree in science or a health related field is preferred with a strong emphasis on science
- Minimum 7 years relevant industry clinical development experience as a Sponsor, with at least 2 years of managing multi-disciplinary project teams
- Experience and understanding of global clinical trial operations, hematology and/or transplant experience welcome
- Experience with all aspects of trial and global site startup and vendor management
- Familiarity with clinical data review and data management processes, including Data Monitoring Committees and conference abstracts/publication preparation
- Forward thinking, data driven and global thinker
- Understanding of thinking beyond clinical development into commercialization; inspection readiness and previous filing experience a plus
- Must be able to travel up to 25%, domestically and internationally
- Clear and succinct verbal and written communication skills
- Ability to deal with competing priorities, strong reasoning, detail oriented and creative problem solving ability is essential
- Ability to work on teams with aggressive timelines and to multi-task in a fast-paced environment with changing priorities
- Excellent knowledge of GCP, ICH and FDA regulations
- Independently motivated to learn and lead
- “Do-what-it-takes” approach to problem solving 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
- Independently motivated, detail oriented and good problem solving ability
- Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities
- Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself
This is an exciting time to join the field of gene therapy in general, and to become a part of the bluebird bio team in particular. bluebird bio is a publicly traded company on the NASDAQ Global Select Market and trades under the symbol BLUE. We offer a fast-paced, dynamic, collaborative, colorful, and scientifically rigorous environment, with all the fun and passion that a start-up provides, plus an excellent benefits package that includes stock options, commuter/parking benefit, etc.
bluebird bio will only accept job applications from candidates who are properly documented with authorization to work in the United States.
Note to Employment Agencies: Please do not forward any agency resumes. bluebird bio is not responsible for any fees related to resumes that are unsolicited.