Clinical Data Manager (contract)

Location
Cambridge, MA, United States
Posted
Oct 20, 2018
Ref
1285123
Discipline
Clinical, Clinical Data
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Contract
Clinical Data Manager

Contract

This is not your typical Clinical Data Management role, come make your mark with us!

bluebird bio's growing Clinical Development Operations team is setting the standard for trial design, conduct and analysis in gene therapy. This Senior Clinical Data Manager position is responsible for data management aspects of clinical studies, The ideal candidate must be comfortable working independently, managing interactions with the DM CRO and cross-functional internal/external project stakeholders (e.g., Clinical Development Operations, Medical Affairs, Biostatistics & Statistical Programming, Regulatory Science, Commercial, Pharmacovigilance, and CROs or other third-party providers of data).

About the Role:
  • Integral member of the Clinical Data Management Team, participating in data management activities in support of clinical studies.
    • Serve as DM representative at team meetings
    • Participate in vendor and stakeholder management
    • Work with the cross-functional representatives for each study to ensure that the database captures all critical data
    • Support data management needs by providing EDC development insight and sharing knowledge of Data Visualization/Data Repository tools. Assist in creating data visualizations, as required, in support of data quality efforts and presentations
    • Gather requirements and provide necessary clinical data reports for internal meetings
  • Perform DM activities through study life-cycle, collaborating with and supervising vendors in setting up, managing and completing trial database systems and CRFs through DB Lock, meeting established timelines and assuring primary goals of high data quality & integrity and analysis-ready data are achieved
    • Participate in eCRF and database design
    • Review Data Management documentation, including DMP, validation checks and CRF Completion Guidelines
    • Review of electronic case report forms (eCRFs) for completeness, content and database considerations
    • Participate in UAT for each database build and work with vendor to assess the impact of any mid-study updates to the EDC database
    • Perform data review for quality issues and general data trends
    • Supervise reconciliation activities using data from external vendors
    • Create reports and or metrics to track and report data and query status
  • Monitor vendor performance and quality of deliverables
  • Define specifications for long-term data collection and integration of external data
  • Manage assigned DM timelines and ensure deliverables/timelines are achieved
  • Work autonomously and collaboratively, escalate issues and reach out for support when needed

About you:
  • Bachelor's Degree or higher in science or health-related discipline
  • Minimum 7 years of relevant industry experience in clinical data management in the pharmaceutical/biotechnology industry with strong CRO oversight
  • Proficient in multiple EDC & ePRO platforms, related processes and data visualization tools, i.e. elluminate, Spotfire, Qlik, etc. (Strong experience in EDC Development and Data Visualization/Data Repository tools is required)
  • Very organized, strong project management skills and creative problem solver
  • Strong knowledge of data management standards (CDASH/SDTM)
  • Understanding of database programming related to data migrations and/or data integrations of disparate data
  • Experience in gene therapy or beta thalassemia TA a plus.
  • Knowledge of related regulations, GCP and Good Clinical Data Management Practices
  • Skillful with medical terminology and advanced background in labs
  • Knowledge of database design and database concepts
  • Good understanding of coding (MedDRA, WHO drug dictionaries)
  • Skilled computer skills including MS office products
  • 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