Data Team Lead - homebased (FSP)

IQVIA; Cape Town; On-site; ZAR 200 000 - 300 000; Full time

Job summary

An established industry player in clinical research services is seeking a detail-oriented Data Management Specialist. This role involves leading data management efforts for clinical trials, ensuring quality and compliance with regulatory standards. You will collaborate with trial customers and internal teams to establish expectations and deliverables, while also overseeing the creation of essential clinical documents. If you have a passion for improving patient outcomes and possess strong data management skills, this opportunity is perfect for you. Join a dynamic team dedicated to advancing healthcare and making a meaningful impact on global health.

Qualifications

• 4+ years of data management experience with a focus on clinical trials.
• Experience in vendor management and leading data management teams.

Responsibilities

• Provide oversight and accountability for clinical trial data management.
• Ensure timely delivery of all data management milestones and compliance.

Skills

Data Management

Clinical Trials Oversight

Vendor Management

Quality Control (QC)

eCRF and Data Collection Tools

Education

BS/BA in Health Sciences

Professional Clinical Experience

Tools

RAVE

Job description

• Provides data management support, oversight and/or accountability for one or more clinical trials.
• Take the lead with the trial customer(s) and other internal and external partners to establish, align and confirm data management expectations.
• Creating, planning, and tracking content, format, quality, and timing of data management deliverables, including, but not limited to, CRF, data review plan, QC plan, oversight plan, database release plan, final datasets, submission plan and archival.
• With the trial customer and other functional partners: – Gathers content and integration requirements for eCRF and other data collection tools.
• Establishes conventions and quality expectations for clinical data.
• Establishes expectations for dataset content and structure.
• Set timelines and follow-up to ensure delivery of all Data Management milestones.
• Performs trial level oversight controls, as appropriate, as described in the oversight plan, QC process and work instructions with minimal DML direction.
• Creates clinical data management documents (including submission package) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency. Ensures compliance with regulatory guidelines and the documentation matrix.
• Ensures real-time inspection readiness of all Data Management deliverables for the trial; Participate in Regulatory Agency and audits, as necessary.
• Helps plan, create and track content, format, quality, and timing of data management deliverables, including, but not limited to, Case Report Form, data review plan, QC plan, oversight plan, database release plan, final datasets, submission plan and archival.
• Ensures deliverables are on time.
• Participates in the assigned clinical working group(s) to ensure that Data Management and Therapeutic Area trial needs and deliverables are met.
• Helps identify and communicate lessons learned, best practices and frequently asked questions at the trial level.
• Presents and trains at investigator and monitor meetings.

Education/Experience

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

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