Sr. Clinical Data Manager, gene therapy

Location
Cambridge, MA, United States
Posted
Sep 23, 2018
Ref
1240431
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Join bluebird bio's enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. The Senior Clinical Data Manager will be responsible for all of the data management aspects of complex gene therapy clinical trials and will work closely with DM CROs and other third-party providers of data services, Clinical Operations, EDC Developers, Pharmacovigilance, and Data Visualization/Data Repositories. Activities includes all DM aspects of performing and delegating tasks from study start-up to close-out according to the study protocols within timelines with the primary goal of ensuring data integrity and ensuring analysis ready data.

About the role:

  • Leads all data management tasks in support of Phase I - IV complex gene therapy clinical studies from study start-up to database lock
  • Leads development of study specific Data Management Plans, Vendor Management plans, Cross-functional data review plans, eCRF completion guidelines, Data Transfer Specifications, eTMF maps, and other CDM documents as appropriate
  • Authors and reviews operational documentation including project timelines, budgets, target metrics, resourcing forecasts, and quality assurance audit reports
  • Leads eCRF design, edit check programming, SAE reconciliation, Medical Coding, and study documentation management,
  • Leads development of data reports and facilitates cross-functional data review for assigned studies or programs
  • Defines, generates, and analyzes metrics across multiple studies, plans and executes risk mitigation strategies
  • Leads data review for accuracy, completeness, and consistency and performs QC as appropriate
  • Represents CDM at the cross-functional study team meetings, providing risk mitigation strategies and input based on best CDM practices
  • Adheres to study and program timelines and quality standards
  • Participates in process development
  • May lead CDM initiatives
  • Presents eCRF training to clinical study teams, sites, and CRAs at Investigator meetings
  • Mentors new and more junior team members


About you:

  • Bachelor's degree, preferably in health science or related field and 5-8 years industry experience
  • Has in-depth and breadth expertise in CDM and broad knowledge of Clinical Development, typically developed through extensive experience leading critical organizational initiatives.
  • Recognized as a technical/professional expert and escalation pathway throughout CDO organization.
  • Successfully solves unique and complex problems that have a critical impact on the business.
  • Anticipates opportunities and problems and offers solutions and best practices.
  • Proven track record of designing, leading and executing initiatives that have meaningful impact on critical goals.
  • Contributes to the development of the CDM strategy as a subject matter expert.
  • Strong project management and meeting facilitation skills
  • Demonstrated experience in writing professional correspondence and clinical study documentation
  • GCP knowledge
  • Strong EDC skills, including Medidata Rave and IBM Health
  • Strong understanding of clinical trial data
  • Ability to work effectively in a collaborative team environment where results are achieved through influence, cooperation, and the incorporation of multiple points of view
  • Independently motivated, detail oriented and good problem solving ability
  • Excellent organizational skills, with an ability to embrace change and multi-task in an extremely fast-paced environment
  • Excellent communications skills and ability to influence across multiple functions
  • Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself