Clinical Data Management (CDM) Programming Specialist - US
Clinical Data Management (CDM) Programming Specialist - US
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1 Vacancy
Job Description
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. Youll 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 (SOPs) and Work Instructions (WINs) when required.
Job requirements
University degree in health-related field or computer science or equivalent experience
At least 3 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: youre at ease to adapt your priority
Attention to details
Fluency in English both written and oral
- Raleigh North Carolina United States
All done!
Your application has been successfully submitted!
Required Experience:
Unclear Seniority
Employment Type
Full-Time
