DM/SDTM Programmer - Europe Home based

IQVIA; Bloemfontein; Remote; USD 60 000 - 100 000; Full time

Job summary

An innovative firm is seeking a skilled Project Manager to oversee database delivery in a remote capacity. This role requires strong communication skills and expertise in SDTM and SAS programming. You will collaborate with various teams to ensure data quality and compliance while managing study eCRFs and dataset structures. Join a leading global provider of clinical research services dedicated to improving patient outcomes. This position offers an exciting opportunity to contribute to groundbreaking medical treatments and work with a dynamic team in the life sciences sector.

Qualifications

• Extensive experience in relational database design and data management.
• Preferred experience with SAS programming and SDTM processes.

Responsibilities

• Collaborate with teams on EDC solution design and implementation.
• Manage data loads and ensure quality of SDTM data.

Skills

Project Management

SDTM Knowledge

SAS Programming

Communication Skills

Data Management Processes

Education

Degree in Life Sciences

Certification in Project Management

Tools

Formedix Ryze

Relational Databases

EDC Systems

Advanced Reporting Tools

Job description

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

Role Overview:

This role within IQVIA is suited for a technically skilled Project Manager with strong communication skills and SDTM knowledge. Experience with SAS programming is highly advantageous. The position is remote, based anywhere in Europe or South Africa.

This is a sponsor-dedicated project, involving direct collaboration with the client 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 data.

Main Responsibilities:

• Collaborate with Sponsor colleagues and CRO Partners on EDC solution design, creation, and implementation.
• Coordinate with Study Data Leads for data receipt planning and oversight during clinical trials.
• Manage data loads from various sources into clinical and operational repositories, including issue review and communication.
• 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 annotations and datasets to ensure adherence to Data Standards and support DE dataset creation.
• Participate in meetings with various teams such as Mission, Submission, Project, Program, JCST, DEM, Biometrics, Clinical & Regulatory Solutions Team (CRST), Early Phase.
• Conduct quality checks and develop standard edit checks for new CRF modules.
• Support audits and inspections as needed, and handle other assigned responsibilities.

Experience Required:

• Extensive experience in relational database design.
• Preferred experience with SAS programming.
• Knowledge of Data Management processes, including:
• SDTM annotated CRF review
• Technical specifications development and review
• Error and warning log review
• Error troubleshooting
• Data mapping and SDTM Controlled Terminology
• Experience in clinical or pharmaceutical fields.
• Experience in Data Management roles.
• Proficiency with relational databases, Clinical Data Management, and EDC Systems.
• Advanced reporting tool skills.
• Strong understanding of federal regulations, Good Clinical Practice, and Good Clinical Data Management Practices.
• Excellent command of English, verbal and written.

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 innovative medical treatments to improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com.