Senior Clinical Data Manager

Senior Clinical Data Manager

TFS HealthScience

Budapest, Hungary

Description

The Senior Clinical Data Manager is part of the Global Biometrics Department within Clinical Development and will work independently on preparing, conducting and completing Clinical Data Management tasks on assigned Study Teams according to company policies, SOP’s and regulatory requirements.

Responsible for Clinical Data Management activities for assigned studies:

  • Act as Lead Clinical Data Manager for assigned data management projects
  • Act as a Project Lead for Biometric-only projects
  • Coordinate work of other Clinical Data Management staff assigned to the project
  • Review Study Protocol
  • Develop CRF or review of sponsor-generated CRFs
  • Develop Database
  • Define and program edit checks
  • Responsible to prepare, finalize and archive all related DM documentation
  • Develop Data Management Plan and Data Management Report
  • Develop Data Validation Plan (including definition of edit checks
  • Develop Data Entry Instructions/ eCRF completion guidelines
  • Coordinate validation of database, edit checks and trial and site settings
  • Performs validation of database, edit checks and trial and site settings in studies where not the responsible CDM
  • Perform CRF handling including logging, tracking and sorting
  • Support the CRAs in study related questions
  • Perform Data cleaning and query handling
  • Ensure completion of Quality Control task for the finalization and transfer of the study database and related documents to the sponsor
  • May coordinate SDTM mapping with the senior programmer when needed
  • Carry out all tasks related to database closure
  • Provide CDs with study documentation to the sites (patient data, audit trail and closed queries)
  • File/archive essential documents
  • Provide metrics and status updates to senior management and project leaders and sponsors if required
  • Train and support Clinical Data Associates and Clinical Data Managers
  • Represent TFS Data Management in sponsor and investigator meetings
  • Responsible to escalate any issues on projects or the need for potential SOP deviations
  • May perform system validation, create test scripts for system validation as well as perform UAT of ePROs in collaboration with the CRA

Requirements

  • Bachelor’s Degree, preferably in life science or nursing, Statistics or Computer Science or equivalent education or equivalent lower education e.g. Associate Degree
  • Minimum 5 years relevant data management experience
  • Experience working within any of the EDC systems Medidata Rave, TrialMaster or Trial Online
  • Experience working within electronic Patient Reported Outcome (ePRO)
  • Proven data management skills
  • Excellent verbal and communication skills
  • Ability to deal effectively with sponsors and internal customers
  • Ability and willingness to travel on occasion

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© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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