Job Description
As an experienced CDM you are the Data Management the (Data Management) (DM) Lead who is, overall responsible for all the 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
You will have a various selection of responsibilities, e.g.:
- 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
- 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
