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Clinical Data Manager

  • Job type: Permanent
  • Location: Rockville
  • Salary: Competitive
  • Job reference: MASL022220181000
  • Sector: Clinical, Clinical Operartions, EPM Scientific
  • Date posted: 22/02/2018
EDC | Phase I-IV Clinical Trials | Industry experience | Multiple locations 

Position Description & Responsibilities


The Clinical Data Manager (CDM) is responsible for managing DM activities in the design, collection and lock of database for multiple phase I-IV clinical trials. As a member of the Biometrics group, the CDM will act as a member of clinical teams and interface with external CROs and external vendors to fulfill many of his or her responsibilities.


Roles and responsibilities include the following:
  • Serve as the Lead Data Manager on multiple studies
  • Design and modify eCRFs and EDC edit checks
  • Responsible for building, review and validation of clinical database
  • Create and maintain project DM documentations
  • Extract and monitor the trial data to identify issues
  • Manage CDM activities in CRO and other vendors
  • Mentor or train other junior members
Position Requirements


Successful candidates will have the following background/experience:
  • Minimum of BS preferably in Health Sciences, Statistics, MIS or Informatics
  • Minimum of 3 experience in Clinical Data Management from CROs or Pharmaceutical companies
  • Experience in electronic data capture (EDC) systems
  • Knowledge of ICH/GCP guidelines and FDA regulations
  • Knowledge of industry data standards (CDISC, SDTM, CDASH)
  • Excellent organizational skills
  • Outstanding interpersonal, oral and written communication skills
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