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