DM/SDTM Programmer - Europe Home based

IQVIA; London; Remote; GBP 50,000 - 90,000; Full time

Job summary

An established industry player is seeking a skilled Project Manager to lead database delivery projects remotely. This role offers the opportunity to work on innovative clinical research projects, ensuring data quality and compliance with industry standards. You'll collaborate with clients and manage data from various sources, contributing to the development of efficient EDC solutions. If you have a strong background in data management and project coordination, this is your chance to make a significant impact in the life sciences sector while enjoying the flexibility of remote work.

Qualifications

• Significant experience in relational database design and data management.
• Preferred experience with SAS programming and SDTM knowledge.

Responsibilities

• Build study eCRFs in Formedix Ryze and define dataset structures.
• Collaborate with sponsors and manage data delivery from vendors.

Skills

Project Management

Communication Skills

SDTM Knowledge

SAS Programming

Relational Database Design

Data Management Processes

Reporting Skills

Knowledge of GCP and GCDMP

Education

Bachelor's Degree in a related field

Tools

Formedix Ryze

EDC Systems

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 skilled Project Manager with strong communication skills and SDTM knowledge. Experience with SAS programming is highly advantageous. The role can be based remotely anywhere in Europe or South Africa.

This position involves working on a sponsor-specific project, directly collaborating 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 format data.

Primary Functions:

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

Main Responsibilities:

1. Collaborate with Sponsor colleagues and CRO Partners to finalize the design, creation, and implementation of EDC solutions.
2. Coordinate with Study Data Leads for data receipt planning and oversee data throughout clinical trials.
3. Process data loads from various sources into clinical and operational data repositories, reviewing and communicating issues as they arise.
4. Program reports and contribute to the standardization of processes and reports for data review and analysis for external partners/vendors and internal teams.
5. Perform formal and ad-hoc analyses and oversee SDTM data quality.
6. Review critical documents and deliverables (SDTM Annotation, SDTM datasets) to ensure adherence to Data Standards and support DE dataset creation.
7. Attend meetings with various teams such as Mission, Submission, Project, Program, JCST, DEM, Biometrics, Clinical & Regulatory Solutions Team (CRST), Early Phase.
8. Perform quality checks and develop standard edit checks for new CRF modules.
9. Support audits and inspections as needed and handle other responsibilities assigned by the company.

Experience Required:

1. Significant experience in relational database design.
2. Preferred experience with SAS programming.
3. Experience with Data Management processes, including:
   • Review of SDTM annotated CRFs
   • Writing and reviewing technical specifications
   • Reviewing log files for errors and warnings
   • Resolving/troubleshooting errors
   • Data mapping and SDTM Controlled Terminology.
4. Previous experience in a clinical or pharmaceutical-related field.
5. Experience in Data Management.
6. Familiarity with relational databases, preferably Clinical Data Management and EDC Systems.
7. Advanced reporting skills.
8. Strong knowledge of federal regulations, GCP, and GCDMP.
9. Excellent command of English, both verbal and written.

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