Careers @ DICE

Clinical Data Management Coordinator

Responsibilities

As Clinical Data Management Coordinator, you will be managing & coaching a team of junior and senior data managers and will be accountable for:

Design and release of clinical databases:

  • Translate a schedule of visits and assessments in an E-CRF Screen design
  • Oversight on development of annotation
  • Develop and perform oversight of UAT test plans
  • Coordinate the release process of database updates

Implement data standards:

  • Oversight on the transformation of the clinical database to CDISC SDTM standards
  • Develop data standards both for DICE and our customers

Data cleaning strategy:

  • Develop validation and edit check plans
  • Define mock tables for patient profiles and listings.
  • Organize the data cleaning process

Clinical coding:

  • Define coding plans (WHODrug, MedDRA), assisted by the medical monitor
  • Prepare clinical coding
  • Propose coded terms for review to medical monitor / sponsor

Reconcile of external data:

  • SAE reconciliation
  • Write data transfer agreements
  • Organize test transfers
  • Reconcile data with the E-CRF

Organization of database lock process:

  • Define type of protocol violations in collaboration with the medical monitor and the trial statistician
  • Define and collect all protocol violations from different sources
  • 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.
  • Write data management report

Requirements

  • You have a university degree or PhD in life sciences/medical, para-medical (Biology, Bio-engineer, Pharmacy, Veterinary, Psychology, etc.), mathematics, or equivalent by experience
  • You have an experience in Clinical Data Management in the context of interventional studies
  • You have good communication and organization skills. You are interested in leading a team of data managers and interacting with our customers
  • Experience with EDC systems.
  • Knowledge of CDISC CDASH and SDTM, WHODrug and MedDRA
  • Ability to work with SAS or SQL is considered as a plus

Key competencies

  • 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
  • Focus with an eye for detail
  • Strong connector who inspires and motivates
  • Excellent verbal and written communication skills in Dutch or French and English
  • Achievement orientation and high energy
  • Entrepreneurial mindset with a customer obsession
  • The ability to work autonomously, as well as collaboratively in a team, in an atmosphere where giving constructive feedback is a must
  • You thrive in an environment where you are constantly challenged and are able to work in structured as well as unstructured settings.

We offer

  • A competitive package with extra-legal benefits
  • A young and dynamic work environment
  • A strong commitment to your professional growth and continuous development
  • A career path that is based on meritocracy with real growth possibilities
  • An easy to reach office & possibilities to work from home. We promote hybrid working arrangements

Join the DICE team!

Check out our current team.