Principal Data Standards Consultant

ICON Plc; Johannesburg; On-site; ZAR 500,000 - 700,000; Full time

Job summary

A leading global healthcare organization in Johannesburg is seeking a Principal Data Standards Consultant to design clinical trials and develop CDISC compliance tools. The ideal candidate will have a Bachelor's degree in a relevant field and extensive experience in clinical data management, particularly with CDISC standards. This role offers a competitive salary and various benefits to support well-being and work-life balance.

Benefits

Health insurance

Retirement planning

Employee Assistance Programme

Flexible benefits

Qualifications

• Experience in clinical data management and standards.
• Advanced proficiency in CDISC standards and regulations.
• Excellent analytical and problem-solving skills.

Responsibilities

• Develop tools for CDISC compliance.
• Collaborate on data collection strategies.
• Maintain training materials on standards.

Skills

CDISC standards

Clinical data management

Analytical skills

Communication skills

Education

Bachelor's degree in Life Sciences or Computer Science

Job description

Principal Data Standards Consultant

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

We are currently seeking a Principal Clinical Data Standards Consultant to join our diverse and dynamic team. As a Clinical Data Standards Consultant at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.

What you will be doing

As a Senior Clinical Data Standards Consultant at ICON Plc, you will be responsible for:

• Developing tools to aid in the implementation and compliance of CDISC, Sponsor, and ICON standards.

• Collaborating with cross-functional teams to define data collection strategies and standards for clinical trials.

• Developing and maintaining training and reference materials related to standards topics including CDASH, SDTM, Terminology, ADaM, define-XML and regulatory submission requirements.

• Managing the development and maintenance of data management processes and tools.

• Keeping abreast of industry trends and regulatory updates related to data standards and ensuring their integration into ICON's practices.

Your profile

To excel in this role, you should possess the following qualifications and attributes:

• A Bachelor's degree in a relevant field (e.g., Life Sciences, Computer Science, or related discipline); advanced degrees are a plus.

• Extensive experience in clinical data management and standards within the pharmaceutical or biotechnology industry.

• Advanced Proficiency in CDISC (Clinical Data Interchange Standards Consortium) standards and relevant regulations (e.g., FDA, EMA).

• Excellent analytical and problem-solving skills with a keen attention to detail.

• Excellent communication and collaboration abilities to work effectively in cross-functional teams.

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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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised 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.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply