Clinical Data Management (CDM) Programming Specialist
Clinical Data Management (CDM) Programming Specialist
20/06/22
Location
Avenue Provinciale 30, Ottignies-Louvain-la-Neuve, Belgium
Vacancy
IDDI (International Drug Development Institute), founded in 1991, is a highly recognized biostatistical and eClinical data service provider in the field of clinical research, providing agile clinical trials services for pharmaceutical, biotechnology, and medical device/diagnostic companies. Together, we want to achieve one objective: support our clients to accelerate the delivery of their drugs and improve people’s health.
To support our growth and commitment to quality and innovation, we are actively looking for a dynamic Clinical Data Management (CDM) Programming Specialist to reinforce our team in Belgium.
As a CDM Programming Specialist, you will develop all SAS programs required to perform CDM activities: reporting, cleaning, coding, SDTM deliverables. This will be achieved in close collaboration with the Lead Clinical Data Managers and peer CDM Programming Specialists.
You will also contribute to initiatives to continuously enhance efficiency of the CDM Programming Specialists deliverables and propose process improvements within your area of expertise.
You will be part of a dynamic and experienced team and report directly to the Team Leader, CDM Programming Specialists. Based on your experience, and to help you thrive in your role and develop your career, you will receive the necessary trainings, mentoring, and coaching from your peers.
Your role:
As a CDM Programing Specialist, you provide expertise and hands-on delivery on all clinical programming activities for Phase I-IV clinical trials.
Your key responsibilities will be to:
Program SAS data validation checks, in collaboration with the Lead CDM
Develop SAS programs required for:
Coding of the clinical data
Transfer of external data
Database unblinding
Reporting
Generate all SDTM deliverables for full FDA submission compliance:
Create SDTM annotated CRF / SDTM specifications
Review SDTM annotations in collaboration with Lead CDM and Biostatistical services team
Program SDTM datasets
Perform quality control (QC) of SDTM datasets by double programming
Review SDTM compliance reports
Create and review metadata specifications (define.xml)
Provide input for Clinical Data Reviewer’s Guide, in collaboration with Lead CDM
Create all dashboard reports
Support the generation of dashboard reporting standards
Participate in the development of standardized template codes and processes
Develop study related key documentation according to Standard Operating Procedures (SOPs)
Your profile:
University degree in Health related field or Computer Science
At least 1 year of SAS programming experience (SAS Base, SAS Macro, SQL)
Minimum 1 year of CDISC (SDTM) experience required: Specific knowledge of SDTMIG V3.3 or higher will be an asset
Previous experience in Clinical Data Management or Biostatistics is preferred
Fluent English with good communication skills, both oral and written
Good time management skills
Eager to learn and stay up-to-date with new CDISC standards and tools (e.g., Pinnacle 21)
High attention to details
Demonstrated ability to prioritize deliverables in collaboration with Project Managers, and Team Leader CDM Programming Specialists
Our Offer:
You will join an international and multi-cultural company that includes over 25 different nationalities (English is the working language) and where employees are the strongest asset.
At IDDI, we offer job stability and growth opportunities through on‑the‑job training and mentoring programs. Working at IDDI will bring you an expertise that is widely recognized in our industry.
Our customers value our flexibility, responsiveness, and proactive approach.
A unique opportunity to work in a friendly, team-oriented, and stimulating environment. We regularly enjoy company-wide events, such as BBQs, family-day outings, sports, and charity fundraisers – giving the chance to share time together.
We offer a competitive salary and benefits package, including meal vouchers, full reimbursement for public transport, hospital insurance, etc. as well as flexibility for a better work-life balance (flexible working hours with home-working opportunities, part-time schedules).
Interested in this challenging position?
Please send your CV and cover letter highlighting your motivation and relevant professional experience for the position by e-mail at careersbelgium@iddi.com