Clinical Data Manager

Boston Biomedical Inc.

Clinical

August 15, 2014

Clinical Data Manager

Summary of Job Responsibilities:

 

The Clinical Data Manager (CDM) is responsible for the performance of data management tasks from study start-up through database lock for assigned clinical research projects, including paper-based and electronic data capture (EDC) studies, and is responsible for overall data quality and documentation on all such projects.

 

The CDM will work on small to mid-sized projects in various indications and may lead a team of CDMs on the project to ensure all the study activities are carried out according to the Standard Operating Procedures of Boston Biomedical. Specific responsibilities on these projects may include but are not limited to:

 

  • Creation, review and finalization of case report forms (CRFs)
  • Development of CRF Completion Guidelines (CCGs)
  • Development of Data Validation Specifications (DVS)
  • Testing of the DVS programs and working with the Database Developer to resolve all findings before releasing into production.
  • Pre-entry preparation of forms for data entry
  • Data Cleaning activities including data review and query generation and integration
  • Coding
  • SAE Reconciliation
  • Handling of external data (e.g., Central Labs, IVRS, etc.)
  • Database Quality Control activities
  • Database Lock
  • Producing and providing metrics on data processing status to the Clinical Project Lead (CPL) and/or Program Manager as needed
  • Work with the other functional groups (e.g., Clinical Operations, etc.) to ensure data management aspects of the project are properly considered and integrated well with the other activities
  • Liaises between study center personnel and the CPL, as appropriate, regarding clinical and/or technical issues
  • Provides software training to Clinical Operations and site personnel, as applicable
  • Trains other data managers on project specific data management processes
  • Interact with vendors as applicable to study protocol

 

 

Job Requirements

  • A BA or BS degree in a related field with a minimum of 3 years of directly-related clinical data management experience. Clinical data management experience may substitute for a portion of the post-secondary educational requirements
  • Working knowledge of International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research
  • Skilled in use of computer technology, including clinical trial databases and applications (e.g., Inform) and ability to learn new applications
  • Be attentive to detail
  • Be flexible and adaptable
  • Excellent interpersonal, communication, and organizational skills with the ability to work both independently and in a team environment

 

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