Senior, Clinical Data Manager- Data Standards

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

Senior Clinical Data Manager- Data Standards

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

As a Senior Manager, Clinical Data Management at ICON, you will be client dedicated, leading the development and implementation of clinical data standards processes that support high-quality data delivery across global clinical trials.

You will play a key role in driving data quality, standards development, data review, and continuous improvement initiatives while partnering with cross-functional stakeholders across the clinical development lifecycle.

Key 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.

You Will Have/Be

• 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.

What ICON Can Offer You

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well‑being and work‑life balance opportunities for you and your family.

Our Benefits Examples Include

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24‑hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well‑being.
• Life assurance
• Flexible country‑specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment.

All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here