Clinical Trial Manager
Clinical-stage, fast-growing gene therapy company
bluebird bio's growing Clinical Development Operations team is setting the standard for trial design, conduct, and analysis in gene therapy across multiple therapeutic areas. Join our collaborative, creative and passionate team as we help bring the promise of gene therapy to patients with severe genetic diseases and cancer. This is not your typical development operations role - come fly with us!
Join bluebird bio's enthusiastic and collaborative Clinical Development Operations (CDO) team by contributing to the overall success of our novel gene therapy approach in Sickle Cell Disease (SCD). This position is a key team member who will be responsible for leading clinical trial strategy and execution (CTSE) inspection readiness (IR) activities and working closely with internal and external team members. Additional responsibilities may include study planning and execution, timelines, budget, and vendor management.
For the Clinical Trial Manager role, this individual should have strong organizational skills, strong knowledge of FDA Regulations and GCP/ICH guidelines. You will ensure trial(s) are managed to the highest quality to ensure safety and effectiveness of bluebird bio's products.
About the role:
Leads, defines, implements, and manages solutions to IR issues in collaboration with CRO partners and cross functional stakeholders. Works closely with the Proactive Clinical Excellence (PACE) team on identified risks/issues.
Acts as the subject matter expert and primary point of contact for relevant functional stakeholders on IR activities and deliverables to provide real-time, proactive advice and guidance to drive towards inspection readiness.
In partnership with the clinical study team, ensures trial compliance is in accordance with regulations, SOPs, and processes. Special focus on vendor management, risk management, and documentation of study team training.
Reviews the electronic trial master file (eTMF) and works with CRO and functional area representatives to ensure an inspection ready eTMF. Works closely with PACE to resolve any systematic issues.
Liaises with PACE to contribute to opportunities to further develop and improve GCP Inspection and compliance strategy, processes, tools, and templates. Escalates when identified gaps may impact inspection readiness.
Leads/owns formal risk assessment activities; review and approve corrective action plans across study, participate in internal/external study related audits.
May perform study site activities, such as on-site or remote monitoring, co-monitoring, training, and motivational visits, as needed.
Review of study specific data, including tables, listings, and figures.
Participate in departmental initiatives such as the development and review of SOPs, Work Instructions and Administrative References.
BS/BA degree required and/or minimum 8 years clinical research experience with experience gained with a CRO, biotech, or pharmaceutical company
Experience in supporting Regulatory Authority (e.g. FDA, EMA, MHRA) GCP inspections is required
Ability to work, lead, coordinate, and project manage activities to drive change within the organization
Pragmatic and solutions oriented
Working knowledge of clinical trial management activities in an outsourced CRO model
Experience with supporting clinical site and/or vendor audits, development of CAPAs and monitoring their implementation to successful resolution
Ability to management multiple projects simultaneously, prioritize workload for teams and function in fast-paced environment
Ability to follow and implement directives, meet deliverable timelines, exercise managerial discretion, advanced analytical/forward thinking and prioritization skills, and escalates when necessary
Experience with eTMF and Quality Management Systems - - Veeva experience preferred
Positive, outgoing, and collaborative attitude with a passion for helping patients using innovative science
Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself
Bluebird Bio, Inc.