DM/SDTM Programmer - Europe Home based

Nanosep AB; London; Remote; GBP 45,000 - 80,000; Full time

Job summary

An innovative company is seeking a skilled Project Manager to oversee Database Delivery for clinical trials. This remote role offers the opportunity to work with diverse teams across Europe and South Africa, managing the creation of study eCRFs and ensuring the integrity of SDTM data. The ideal candidate will possess strong communication skills and a solid understanding of data management processes, including SAS programming. Join a forward-thinking organization dedicated to improving patient outcomes through cutting-edge clinical research services.

Qualifications

• Extensive experience in relational database design is essential.
• Preferred experience with SAS programming and SDTM knowledge.

Responsibilities

• Manage Database Delivery from external vendors for clinical trials.
• Build study eCRFs and ensure quality and completeness of SDTM data.

Skills

Project Management

SDTM Knowledge

SAS Programming

Communication Skills

Data Management Processes

Education

Bachelor's Degree in a relevant field

Tools

Formedix Ryze

Relational Databases

Job description

Location: Remote (UK, Spain, South Africa, Hungary, Ireland, France, Italy, Portugal, Czech Republic, Bulgaria, Belgium)

Role Overview:

This unique role within IQVIA is suited for a technically minded Project Manager with strong communication skills and SDTM knowledge. Experience with SAS programming is highly advantageous. The role can be based remotely from anywhere in Europe or South Africa.

This position involves working directly with the client on a sponsor-dedicated project to manage Database Delivery from external vendors.

The main responsibilities include building study eCRFs in Formedix Ryze (Certara), defining dataset structures for data transfer specifications, and ensuring the quality and completeness of SDTM format data.

Primary Functions:

• Build study eCRFs in Formedix Ryze (Certara)
• Define dataset structures for data transfer specifications
• Ensure quality and completeness of SDTM data

Main Responsibilities:

• Collaborate with Sponsor colleagues and CRO Partners on EDC solutions design, creation, and implementation.
• Coordinate with Study Data Leads for data receipt planning and oversight during clinical trials.
• Process and review data loads from various sources into clinical and operational data repositories.
• Program reports and contribute to process and report standardization for data review and analysis.
• Perform formal and ad-hoc analyses and oversee SDTM data quality.
• Review SDTM annotation and datasets to ensure compliance with Data Standards and support DE dataset creation.
• Participate in meetings with various teams (Mission, Submission, Project, Program, JCST, DEM, Biometrics, CRST, Early Phase).
• Perform quality checks and develop standard edit checks for new CRF modules.
• Support audits and inspections as needed and handle additional responsibilities as assigned.

Experience Required:

• Extensive experience in relational database design.
• Preferred experience with SAS programming.
• Knowledge of Data Management processes, including:
• Reviewing SDTM annotated CRFs
• Writing and reviewing technical specifications
• Analyzing log files for errors and warnings
• Resolving data errors and troubleshooting
• Data mapping and SDTM Controlled Terminology

Additional requirements include prior experience in clinical or pharmaceutical fields, familiarity with relational databases and EDC systems, advanced reporting skills, and knowledge of regulations and best practices in clinical data management. Proficiency in English is essential.

IQVIA is a leading global provider of clinical research services, insights, and healthcare intelligence to the life sciences and healthcare industries. We aim to accelerate the development and commercialization of medical treatments to improve patient outcomes worldwide. Learn more at https://jobs.iqvia.com.

We value diverse talent, curiosity, and innovation. Everyone at IQVIA contributes to our goal of improving lives through our work. Thank you for your interest in growing your career with us.

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