Data Team Lead - homebased (FSP)

IQVIA; Bloemfontein; On-site; ZAR 400,000 - 600,000; Full time

Job summary

A leading global provider of clinical research services seeks a Data Management Specialist to oversee data management for clinical trials. The role involves leading data management expectations, ensuring quality control, and managing deliverables. Candidates should have a degree in Health Sciences and substantial experience in data management.

Qualifications

• At least 4 years of Data Management experience.
• At least 3 years of lead or co-lead experience.
• Experience with vendor management.

Responsibilities

• Lead data management expectations with trial customers and partners.
• Create and track data management deliverables.
• Ensure quality and compliance of clinical data.

Skills

Data Management

Vendor Management

Quality Control

Communication

Education

BS/BA degree in Health Sciences

Tools

RAVE

Job description

Data Management Specialist Job Description

The Data Management Specialist provides data management support, oversight, and accountability for one or more clinical trials.

Responsibilities include:

1. Leading with trial customers and internal/external partners to establish, align, and confirm data management expectations.
2. Creating, planning, and tracking content, format, quality, and timing of data management deliverables, including CRFs, data review plans, QC plans, oversight plans, database release plans, final datasets, submission plans, and archival.
3. Gathering content and integration requirements for electronic Case Report Forms (eCRF) and other data collection tools with trial customers and functional partners.
4. Establishing conventions and quality expectations for clinical data.
5. Setting expectations for dataset content and structure.
6. Setting timelines and following up to ensure delivery of all Data Management milestones.
7. Performing trial-level oversight controls as described in the oversight plan, QC process, and work instructions with minimal DML direction.
8. Creating clinical data management documents, including submission packages, ensuring quality, scientific accuracy, organization, clarity, and compliance with regulatory guidelines.
9. Ensuring real-time inspection readiness of all Data Management deliverables and participating in regulatory agency audits as necessary.
10. Planning, creating, and tracking content, format, quality, and timing of data management deliverables to ensure timely delivery.
11. Participating in clinical working groups to meet Data Management and Therapeutic Area trial needs and deliverables.
12. Identifying and communicating lessons learned, best practices, and FAQs at the trial level.
13. Presenting and training at investigator and monitor meetings.

Education and Experience

• BS/BA degree or higher, preferably in Health Sciences, or equivalent professional clinical experience.
• At least 4 years of Data Management experience.
• At least 3 years of lead or co-lead experience.
• Vendor management experience.
• Experience with RAVE.

This role is not eligible for UK visa sponsorship.

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