Data Team Lead - homebased (FSP)

IQVIA; Centurion; On-site; ZAR 300 000 - 600 000; Full time

Job summary

An established industry player is seeking a skilled Data Manager to oversee clinical trials and ensure high-quality data management deliverables. In this pivotal role, you will lead interactions with trial customers and partners, set data management expectations, and ensure compliance with regulatory guidelines. Your expertise will be crucial in creating and tracking essential documents, maintaining inspection readiness, and participating in audits. This opportunity offers a chance to make a significant impact in the clinical research field while collaborating with diverse teams to drive successful trial outcomes. If you have a passion for data integrity and a commitment to excellence, this role is for you.

Qualifications

• 4 years of data management experience required.
• 3 years of lead/co-lead experience preferred.

Responsibilities

• Oversee data management for clinical trials ensuring quality and compliance.
• Establish expectations and timelines for data management deliverables.

Skills

Data Management

Clinical Trials Oversight

Vendor Management

Quality Control

Communication Skills

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.