- IDDI - International Drug Development Institute
- Ottignies-Louvain-la-Neuve, Belgium (Remote)
- Full-time
Clinical Data Management (CDM) Programming Specialist
- IDDI - International Drug Development Institute
Ottignies-Louvain-la-Neuve, Belgium
Full-time
Published:
- IDDI - International Drug Development Institute
Ottignies-Louvain-la-Neuve, Belgium
Full-time
Published:
JOB DESCRIPTION:
As a CDM programming specialist, you will join a dynamic team of 10 data programmers and play a key role in all clinical trials to develop and maintain qualitative SAS programs, ensuring that accurate clinical data is analysed and reported in the format required by regulatory agencies.
For each clinical trial, you will collaborate with various stakeholders (including trial teams and clients) to gather data reporting requirements and resolve any data issues that may arise. This role requires extensive SAS programming experience in a clinical trial environment to ensure high quality and autonomy after a thorough onboarding process.
This position offers you the opportunity to play a pivotal role in delivering exceptional services to our clients. You'll be part of an environment that fosters growth through various learning initiatives (such as on-the-job learning, e-learning, and conferences), ensuring you stay up to date with the latest programming and new AI technologies.
YOUR RESPONSIBILITIES:
JOB REQUIREMENTS:
As a CDM programming specialist, you will join a dynamic team of 10 data programmers and play a key role in all clinical trials to develop and maintain qualitative SAS programs, ensuring that accurate clinical data is analysed and reported in the format required by regulatory agencies.
For each clinical trial, you will collaborate with various stakeholders (including trial teams and clients) to gather data reporting requirements and resolve any data issues that may arise. This role requires extensive SAS programming experience in a clinical trial environment to ensure high quality and autonomy after a thorough onboarding process.
This position offers you the opportunity to play a pivotal role in delivering exceptional services to our clients. You'll be part of an environment that fosters growth through various learning initiatives (such as on-the-job learning, e-learning, and conferences), ensuring you stay up to date with the latest programming and new AI technologies.
YOUR RESPONSIBILITIES:
- Create the SAS clinical databases that will be used by the biostatisticians for their analyses (SDTM format):
- Define the SDTM conversions, specifications and annotations;
- Program the SDTM datasets, correct any issues and release the datasets into production.
- Produce all deliverables required by the FDA and EMA agencies;
- Interact closely with the Biostatistician and Data Manager to ensure SAS programs fits with biostatistical analyses needs;
- Develop all SAS programs required to perform manual data cleaning (develop validation checks), data coding, data reconciliation:
- You are the owner of the un-blinding programs;
- Participate in the effort of standardization within the department.
- Innovate in the development of advanced Clinical Intelligence reporting (Create all dashboard reports, correct any issues and release the reports in production; Support the generation of dashboard reporting standards;
- Assist in developing and updating the Standards Operating Procedures (SOP’s) and Work Instructions (WIN’s) when required.
JOB REQUIREMENTS:
- University degree in health-related field or computer science or equivalent experience;
- At least 5 years’ experience in clinical data management;
- Demonstrate extensive SAS programming experience in a clinical trial environment;
- CDISC SDTM experience;
- Good communication skills;
- Capable to work under tight deadlines;
- Agile-minded: You’re at ease to adapt your priority;
- Attention to details;
- Fluency in English, both written and oral.
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