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DM/SDTM Programmer - Europe Home based

Nanosep AB

United Kingdom

Remote

GBP 50,000 - 80,000

Full time

2 days ago

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Job summary

A leading company is seeking a technically minded Project Manager to oversee Database Delivery and manage client interactions. The role focuses on building eCRFs, defining data structures, and ensuring SDTM data quality. Ideal candidates will possess strong communication skills and relevant experience in clinical data management.

Qualifications

Experience with SAS programming preferred.
Substantial experience in relational database design.
Experience with Data Management processes.

Responsibilities

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

Skills

Communication

SDTM Knowledge

SAS Programming

Database Design

1 week ago Be among the first 25 applicants

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

Role Overview

This unique role within IQVIA lends itself to a technically minded Project Manager with strong communication skills and SDTM knowledge. Having experience with SAS programming will also be a huge benefit. The role can be based remotely from anywhere in Europe or in South Africa.

This role is part of a sponsor dedicated project where you will be working with the client directly to manage Database Delivery from external vendors.

The primary functions of this role will be to build study eCRFs in Formedix Ryze (Certara), define structure of datasets that are part of data transfer specifications and ensure 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 format data

Main Responsibilities

Collaborate with Sponsor colleagues and CRO Partners to finalize the design, creation, and implementation of EDC solutions.
Work with Study Data Leads to plan for data receipt and oversee it throughout clinical trials.
Process data loads from various sources into clinical and operational data repositories, including reviewing and communicating issues.
Program reports and contribute to the standardization of processes and reports for data review and analysis for external partners/vendors and internal teams.
Complete formal and ad-hoc analyses and oversight of SDTM data.
Review critical documents/deliverables (SDTM Annotation, SDTM datasets) to ensure consistent use of Data Standards and support the creation of DE datasets.
Attend meetings with various teams (Mission, Submission, Project, Program, JCST, DEM, Biometrics, Clinical & Regulatory Solutions Team (CRST), Early Phase)
Perform quality checks and create standard edit checks for new CRF modules.
Support audits and inspections as required and handle other responsibilities and projects assigned by the Company.

Experience Required

Substantial experience in relational database design.
Substantial experience with SAS programming preferred.
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.

Prior experience in a clinical or pharmaceutical-related field.
Prior experience in a Data Management-related field.
Experience with relational databases, preferably Clinical Data Management and EDC Systems.
Advanced familiarity with reporting tools.
Advanced knowledge of federal regulations, Good Clinical Practice, and Good Clinical Data Management Practices.
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 create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

Seniority level

Seniority level
Entry level

Employment type

Employment type
Full-time

Job function

Job function
Information Technology
Industries
Software Development

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