Senior Data Manager

  • Belgium
  • Not disclosed
  • 80 %
  • 23 days
  • 8 days ago
  • 15

Domains of expertise

  • Data Management Stats
    • Clinical Data Director
    • Clinical Data Entry Manager
    • Clinical Data Manager

Description

Design and release of clinical databases

  • Screen design
  • Oversight on development of annotation 
  • Oversight of test plans 
  • Decide when clinical database can be put in production
  • Initiate process to release database update following protocol amendments and/ or updated in regulatory guidelines 

Clinical coding 

  • Define coding plans (WhoDrug, MedDra) 
  • Prepare clinical coding 
  • Propose coded terms for review to medical monitor / sponsor 

Data cleaning strategy 

  • Development of automatic edit check plan
  • Development of manual edit check plans 
  • Development of self-evident correction plans 
  • Define mock tables for patient profiles and listings. 
  • Initiate process to update data cleaning strategy following protocol amendments and/ or updated in regulatory guidelines  

Periodic reconciliation of external data 

  • SAE reconciliation 
  • Periodic reconciliation for DSUR, yearly reporting to EC, … 

Organization of database lock process 

  • Reconciliation of external data 
    • Define sources of all external data based on study protocol 
    • Create data transfer specifications 
    • Organize test transfers 
    • Organize transfers of actual data based on blinding plan ( randomization, biomarkers, etc)
  • Define type of protocol violations in collaboration with the medical monitor and the trial statistician
  • Define and collect all protocol violations from different sources ( clinical operations) 
  • Prepare list for medical coherence review for the medical monitor 
  • Prepare and participate to the data review meeting
  • Decide when the database can be locked and be unblinded. 

You are responsible for following international guidelines ICH, EMA, etc and to update standard operating procedures when needed. You train your team members in the latest guidelines and updates of SOP.

 

Skills required

Ideal work experience and education

  • You have a university degree or PhD in life sciences/medical, para-medical (Biology, Biomedical Sciences, Pharmacy, Veterinary etc.), mathematics or equivalent by experience; 
  • You bring at least five years of experience in Clinical Data Management for interventional studies;
  • Experience with EDC systems is considered as a plus: Inform, medidata, other 
  • Knowledge of CDISC CDASH and SDTM, WhoDrug and MedDRA
  • Ability to work with SAS or SQL is considered as a plus 

 

What makes you stand out 

  • Focus with an eye for detail
  • Excellent verbal and written communication skills in Dutch or French and English
  • Achievement orientation and high energy 
  • Entrepreneurial mindset with a customer obsession; 
  • Can do attitude and the flexibility to engage in a variety of tasks
  • Growth mindset to continuously learn and stay on top of latest developments
  • The ability to work autonomously, as well as collaboratively in a team, in an atmosphere where giving constructive feedback is a must
  • Mission location(s)

    • Europe
      • Belgium
        • Brussels
        • Flanders region
          • Antwerp
    The Freelancer must resides in the same country as the mission's location
  • Mission start date

    As soon as possible

  • Experience level

    4 - 10 Years experience in this/these domain(s)

  • Fee proposed

    Not disclosed

  • Reference number

    201116-273-CORTEX-33510
  • FTE Required

    80 %

  • Contract duration

    6 month(s)

  • Contract renewal?

    can be renewed

Job application