Data Team Lead - Remote (US) - homebased (FSP)

The Data Team Lead is responsible for managing data for clinical trials, leading data management activities, and ensuring compliance with regulatory standards. The role involves coordinating with internal and external partners, overseeing data deliverables, and training team members.

Location: Centurion, South Africa

Responsibilities

• Provides data management support, oversight and/or accountability for clinical trials.
• Lead with trial customer(s) and partners to establish data management expectations.
• Create, plan, and track data management deliverables including CRF, data review plan, QC plan, oversight plan, database release plan, final datasets, submission plan, and archival.
• Gather content and integration requirements for eCRF and other data collection tools.
• Establish conventions and quality expectations for clinical data.
• Set timelines and follow-up to ensure delivery of Data Management milestones.
• Perform trial level oversight controls.
• Create clinical data management documents ensuring quality, scientific content, and compliance.
• Ensure real-time inspection readiness of Data Management deliverables.
• Participate in regulatory audits.
• Help plan, create, and track content, format, quality, and timing of data management deliverables.
• Ensure deliverables are on time.
• Participate in clinical working groups.
• Identify and communicate lessons learned and best practices.
• Present and train at investigator and monitor meetings.

Requirements

• BS/BA degree or higher in Health Sciences or related field.
• 5 years Data management experience.
• 3 years lead/co-lead experience.
• Vendor Management experience.
• RAVE experience.