Clinical Data Management (CDM) Programming Specialist
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 the US (Raleigh, NC).
CLINICAL DATA MANAGEMENT (CDM) PROGRAMMING SPECIALIST
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.
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
- 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 (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)
- 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
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 health, dental and vision insurance plans, short- and long-term disability insurance, life insurance as well as flexibility for a better work-life balance (flexible working hours, home-working opportunities, paid time off).
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 careersUSA@iddi.com (to the attention of Ms. Marie-Pierre Debroas).