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Senior Clinical Data Manager

Cambridge, Massachusetts 02142

Post Date: 04/04/2018 Job ID: 1922 Job Category: Clinical: Data Management

The Senior Clinical Data Manager is responsible for the data management aspects of clinical trials and works closely with DM CROs and other third-party providers of data services, Clinical Operations, EDC Developers, Drug Safety, and Data Visualization/Data Repositories. Activities includes all DM aspects of collaborating and or supervising vendors in setting up, managing and completing trial database systems and CRFs through DB lock within timelines with the primary goal of ensuring data integrity and ensuring analysis ready data.

Responsibilities:
  • Lead DM for assigned projects
  • Oversee vendor performance and deliverables
  • Manage assigned DM timelines and ensure deliverables/timelines are met
  • Work with the cross-functional representatives for each study to ensure that the database captures all critical data
  • Direct the coordination, gathering and providing necessary clinical data/reports for internal DMC meetings
  • Provide data management support (directly and/or through vendor management) for ongoing trials:
  • Understand/follow and create Data Management Plans (DMP), validation specifications, etc.
  • Participate in UAT for each database build/work with vendor to understand the impact of any mid-study updates to the EDC database.
  • Review of electronic case report forms (eCRFs) for completeness, content and database considerations
  • Perform data review for quality issues and general data trends
  • Supervise reconciliation activities using data from external vendors
  • Managing and creating reports and or metrics to track and report data/query status
  • Assist in in the development of data management standard working practices.
  • Assist in creating data visualizations, as required, for presentations
  • Participate in data management activities in support of new clinical trials:
  • Serve as DM representative at study team meetings
  • Provide input into study protocols from a data management perspective
  • Participate in eCRF and database design
  • Generation of Data Management deliverables including Data Validation Specifications and CRF Completion Guidelines
  • Work on process improvement initiatives


Qualifications:
  • 7+ years of relevant work experience in clinical data management in the pharmaceutical/biotechnology industry with strong CRO oversight.
  • B.S. or higher
  • Proficient in multiple EDC platforms, related processes and data visualization tools, i.e. Comprehend, Spotfire, etc.
  • Very organized and creative problem solver
  • Strong knowledge of global standards data management standards (CDASH/SDTM)
  • Experience in oncology & hematology studies
  • 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
  • Excellent written, verbal and communication skills
  • Ability to handle multiple projects and be a team player

Demeika Roberts

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