Clinical Trial Manager, Hemoglobinopathies

Location
Cambridge, MA, United States
Posted
Nov 08, 2018
Ref
1386514
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
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!

The location of this position is Cambridge, MA- onsite

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 transfusion-dependent thalassemia (TDT). Reporting to a Sr. Clinical Trial Manager, you will be responsible for managing two global Phase 3 TDT clinical studies. Responsibilities include study planning and execution, timelines, budget, and vendor management. In this position you will be a key team member who will effectively lead the implementation, management and close-out of the two Phase 3 TDT clinical trials to support Regulatory filings, with a focus on inspection readiness.

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. Utilize your experience with working independently, influencing , and leading a cross functional internal and external team. You will ensure trial(s) are managed to the highest quality to ensure safety and effectiveness of bluebird bio's products.

About the role:
  • Responsible and accountable for two concurrent global, Phase III clinical studies that adhere to ICH/GCP standards
  • Oversight of vendors including CROs, Central Labs and independent contractors; actively participates in development of study documents and plans
  • Manage trial budget
  • Ensure data entry/cleaning milestones (including data snapshots) are met
  • Coordinate patient treatment planning and drive traceability procedures for investigational products
  • Accountable for oversight and maintenance of Central Files (eTMF), including ensuring files are inspection-ready for filings
  • Leads/owns formal risk assessment activities; review and approve corrective action plans across study, participate in internal/external study related audits
  • May perform research site activities, such as on-site or remote monitoring, co-monitoring, training, and motivational visits, as needed
  • Review of study specific data review, including tables, listings and figures
  • Communicates study progress, risk and issues effectively throughout the internal organization and with outsourced partners
  • Participate in departmental initiatives such as the development and review of SOPs, Work Instructions and Administrative References


About you:
  • BS/BA/RN Degree in a life science or a health-related field is preferred, with a minimum of 5 years relevant industry clinical development experience and at least 3 years of managing multi-disciplinary project teams
  • Biopharmaceutical/Biotech experience strongly preferred
  • Experience and understanding of global clinical trial operations; preference in the rare disease space
  • Excellent knowledge of GCP, ICH and FDA regulations; working knowledge of international regulations in the EU preferred
  • Experience with eTMF and Quality Management Systems - Veeva experience preferred
  • Familiarity with clinical data review and data management processes, including Data Monitoring Committees
  • Prior experience supporting regulatory filings and inspections and audits desirable
  • Demonstrates a drive for solutions, a strong sense of urgency, keen attention to detail, and the ability to plan, organize and successfully execute in an environment under time and resource pressure
  • Ability to foster relationships with vendors, clinical sites and cross-functional colleagues based on trust and collaboration
  • Excellent and transparent communication skills and ability to influence across multiple functions
  • The ability to independently lead several projects simultaneously, an adaptive working style and a creative and thoughtful approach to problem solving
  • Thrives in a fast-paced and evolving environment
  • Must be able to travel up to 25%, domestically and internationally
  • 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