Senior Clinical Data Manager (Remote/Hybrid)

1w1 week ago

P95

ZA · Full-time · ZAR 800,000 – ZAR 1,200,000

About this role

The Senior Clinical Data Manager leads and oversees end-to-end clinical data management activities for global studies, ensuring high-quality, timely, and compliant data deliverables. This role provides operational oversight to Clinical Data Managers, Data Coordinators, and Associates. It serves as the primary study-level data management contact or co-lead, adhering to standards and requirements.

Day-to-day involves tracking study progress, identifying risks, and implementing corrective actions. Oversee regular data cleaning, query management, and data reconciliation with cross-functional partners. Review data listings, reports, and metrics for consistency, accuracy, and completeness.

Lead internal study team meetings and contribute to sponsor meetings like Study Kick-Off. Support onboarding and training of new team members while fostering collaboration with Line Manager and stakeholders. Provide mentorship as a subject-matter resource on complex tasks.

Contribute to financial oversight by monitoring budgets, tracking scope against SOW, and flagging out-of-scope activities. Ensure compliance with SOPs, regulatory guidelines, and sponsor requirements. Participate in audits and support new technologies and process innovations.

Requirements

Minimum of 6 years hands-on experience in Clinical Data Manager project lead role
Preferably in global Phase II–III oncology trials with CRO background
Proven end-to-end data management lifecycle expertise including database build, data cleaning, medical coding, SAE reconciliation, data review
Experience leading DM activities in compliance with regulatory guidelines and sponsor requirements
Familiarity with clinical trial data standards and audit preparation
Ability to oversee team members and provide mentorship on complex DM tasks

Responsibilities

Serve as the primary study-level Data Management (DM) lead or co-lead, providing strategic direction
Provide day-to-day oversight and guidance to Clinical Data Managers, Data Coordinators, and Data Associates
Lead internal study team meetings and contribute to sponsor meetings including Study Kick-Off
Track study progress, identify risks, and implement corrective and preventive actions
Monitor study budgets for DM activities, track effort against Scope of Work, and escalate variances
Perform and oversee data cleaning activities to ensure timely, high-quality, audit-ready data
Coordinate data review cycles, query management, and data reconciliation with cross-functional partners
Ensure compliance with SOPs, work instructions, regulatory guidelines, and sponsor requirements