Clinical Data Manager

Do you have a Scientific Master or PhD degree, experience in Clinical Data Management and you want to grow further in Data Management? Don't hesitate and apply today!

Job Description

As an (experienced) CDM you are the Data Management Lead who is, overall responsible for all the Data Management (DM) activities from the projects on which you are assigned. 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 ensure that trustful, transparent, clean and consistent SDTM data is delivered to the Statistical team at database lock.

Responsibilities

• Review and testing of the Data Collection Tool (EDC Tool or eSource Tool)
• Create eCRF completion Guidelines and provide EDC training at investigator meetings
• Attend the Kick-off Meeting with the client and involved parties
• Development of the Data Management Plan
• Defining and validating the SDTM cleaning package
• Validation of the SDTM 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

Requirements

• Master/PhD of Science (Biomedical Sciences, Bio Engineering, Epidemiology, Pharmaceutical Sciences, Biology, … )
• Fluent and proficient knowledge of English
• Data minded
• Eye for detail
• Very proficient communication skills
• Stress resistant
• Well-organized
• A real team player
• Preferably, a minimum of 2 years of experience within Clinical Trial Data Management

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