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Clinical Trial SME
ICON Plc
·
3.4
Johannesburg, Gauteng
Full-time
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Job details

Pay information not provided
Full-time
Johannesburg, Gauteng

Full job description

Clinical Trial Subject Matter Expert (CT SME)

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.



As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.



With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Firecrest Clinical is part of the ICON plc Group and produces highly visual and engaging products for the Clinical Trial Industry. Firecrest products help improve Site performance by delivering innovative and effective training to sites while complying with Industry Standards. As an organisation responsible for the development of clinical training for medical staff, the Clinical Trial Advisor role is critical to the delivery of accurate and high quality training products to our clients.

What you will be doing

  • Uses clinical research experience, accrued from previous clinical research roles, to assist colleagues in the production of accurate and engaging components for our stakeholders.

  • Works actively, independently or with the team (depending on the task), to create the high quality digital solutions in line with the sponsor's needs and expectations, and within sponsor delivery timelines.

  • Advises and supports the production team (Instructional Designer, Graphic Designer, Product Testing Analysts) on clinical trial related matters, across therapeutic areas.

  • Ensures technical accuracy of the products/solutions at each stage of the product development, while ensuring the clinical content adds maximum value for end users (Sponsors, Site Staff, Investigators, and Patients).

  • Conducts comprehensive review of study documentation provided by the sponsor

  • Attends sponsor meetings and assists Project Manager (PM) as required to support product development

  • Communicates/escalates protocol-related queries to the Project Manager (PM)/In Team Lead (ITL).

  • Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required.

  • Assumes additional responsibilities as directed by CTSME Supervisor and/or other management.

  • Identifies operational efficiencies and process improvements, contributing to an environment of continuous learning and improvement.

  • Depending on level of experience, assists in training and mentoring of less experienced CT SMEs.

  • Ensure the maintenance of a high personal level of knowledge concerning current regulation and changes within the clinical research industry by means of internal support and individual learning.

Your profile

  • B.Sc. (Hons) in life science or equivalent.

  • Minimum 2-3 years' experience as a CRA/site coordinator/study nurse within the clinical research industry

  • Experience across different trial phases and therapeutic areas

  • Excellent practical knowledge and understanding of the complexity of clinical trials and experience with different clinical trial systems/vendors

  • Excellent analytical skills and attention to detail

  • Ability to work independently as well as part of the project team, depending on the solution requirements

  • Ability to produce accurate work within tight deadlines

  • Knowledge of ICH GCP guidelines and experience in reviewing study-related documentation

  • Excellent written and verbal communication in English

#LI-JD1



Employment with ICON is contingent upon having the legal right to work in the country where the role is based.



Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.



Benefits may include:

  • Competitive base salary and performance related incentives
  • Health and wellbeing programmes including medical, dental, and vision coverage where applicable
  • Retirement and pension plans
  • Life assurance and disability coverage
  • Employee assistance programmes and wellbeing resources
  • Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.



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



Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.



If you require reasonable accommodations during the recruitment process, please let us know or submit a request .

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