Senior Clinical Data Standards Leader

ICON Strategic Solutions; Johannesburg; On-site; ZAR 900,000 - 1,300,000; Full time

Benefits offered by this job

Annual leave entitlements

Health insurance offerings

Retirement planning offerings

Global Employee Assistance Programme

Life assurance

Country-specific optional benefits

Job summary

ICON Strategic Solutions is seeking a Senior Clinical Data Manager- Data Standards to lead the development and implementation of clinical data standards across global trials. You will drive data quality, governance, and process improvements while collaborating with CTR, CTC, and CFDR teams.

You will mentor more junior staff, ensure regulatory compliance, and translate strategic objectives into actionable operational plans in a sponsor-dedicated model.

Qualifications

• Bachelor's degree in Life Sciences, Health Sciences, or a related discipline.
• Extensive Clinical Data Management experience within a CRO, biotechnology, or pharmaceutical environment.
• Strong experience in process development, project management, stakeholder engagement, and cross-functional collaboration.
• Proven ability to build and operationalise new processes and ways of working.
• Experience in data quality, standards development, data review, edit checks, data listings, or standards library management.
• Strong understanding of clinical trial processes, regulatory requirements, and ICH-GCP.
• Excellent communication, problem-solving, and leadership skills.
• An entrepreneurial mindset with the ability to thrive in a developing and evolving function.

Responsibilities

• Lead the development and operationalisation of clinical data standards processes and best practices.
• Drive initiatives related to data cleaning, data quality, edit checks, data listings, and standards library management.
• Partner closely with Clinical Trial Reporting (CTR), Clinical Trial Configuration (CTC), and Cross-Functional Data Review (CFDR) teams.
• Establish governance, workflows, and quality standards to support clinical trial delivery.
• Lead and mentor Associate Manager-level team members while fostering a culture of continuous improvement.
• Collaborate with cross-functional stakeholders to translate strategic objectives into operational execution.
• Identify risks, drive process improvements, and promote data quality across the clinical data lifecycle.

Skills

Data standards

Stakeholder engagement

Leadership

Data quality

Process development

Clinical trials

Education

Bachelor's degree in Life Sciences

Tools

EDC systems

CTMS

Job description

ICON Strategic Solutions is seeking a Senior Clinical Data Manager- Data Standards to lead the development and implementation of clinical data standards across global trials. You will drive data quality, governance, and process improvements while collaborating with CTR, CTC, and CFDR teams.

You will mentor more junior staff, ensure regulatory compliance, and translate strategic objectives into actionable operational plans in a sponsor-dedicated model.