Experienced Clinical Data Manager

21 August 2020
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Description

For one of our clients, TRIUM is looking for an experienced Clinical Data Manager (CDM) to reinforce their team.

Function

As a CDM, you are the Data Management Lead who is, overall responsible for all the DM activities related to the projects on which you are assigned too. You are the owner of the clinical SDTM database for your clinical studies and will serve as the Point of Contact towards all involved parties and towards the client. You will deliver clean clinical SDTM data to the Statistician within the pre-defined timelines and according to the guidelines described in the Data Validation Plan and Data Management Plan.

In addition, you will be responsible to set-up all necessary data flows, documents and plans for the data management part of a clinical trial and be responsible for the data cleaning activities related to the clinical database for such trial.

This includes, but is not limited, to following tasks:

  • Review and testing of the Data Collection Tool (EDC Tool or eSource Tool)
  • Create eCRF completion Guidelines and provide EDC training at investigator meeting
  • Attend the Kick-off Meeting with the client and involved parties
  • Development of Data Management Plan
  • Communication with all involved parties
  • Defining and validating the SDTM cleaning package
  • Validation of the SDTM clinical database based on the applicable implementation guide and agreed standards with the client
  • Define and agree on (customized) progress and status reports
  • Create/review the Data Transfer Agreements with all External Data Providers
  • (Ensure the) Data cleaning of subject data by generating queries towards the sites/investigators (check on inconsistent, missing, incorrect or unclarified data)
  • Coding of therapies and medical events
  • Serious Adverse Event reconciliation
  • Create the Protocol Deviation Criteria List and handle/detect the Protocol Deviations (minor/major)
  • Communication with all involved parties (EDC, STAT, MA, Clinical teams, Client, External Data Providers, Medical Writing, Project Manager Biometrics)
  • Processing of (Interim) Database Locks and provide the necessary data for Safety Reviews, DSMBs, Safety Committees
  • Ensure the submission package is complete for your project

Profile

You have/are:

  • a Master or PhD degree in sciences or equal by relevant experience
  • a minimum two years of experience within the clinical data management field
  • good knowledge of MS Office
  • solid knowledge of CDISC/SDTM standards
  • proficient in English
  • a teamplayer with excellent communication skills who likes to take ownership
  • a flexible attitude and problem-solving mindset
  • proactive, transparant and organized
  • quality-minded, accurate & efficient with an eye for detail while making the necessary links
  • stress-resistant while respecting timelines

Offer

Our client offers:

  • A great working atmosphere in a well-established, dynamic and professional DM team
  • Full time assignment, starting asap – minimum 6 months (with the potential to be prolonged)
  • Office located in the province of Antwerp with flexible working hours and home office days possible

Interested in this job?

Send us your CV and motivation to: staffing@triumclinicalconsulting.com