Clinical Trial Sme

6 months ago

Johannesburg, South Africa Icon plc Full time

Clinical Trial SME

Location: Office-based in Johannesburg, Warsaw or Sofia

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.

If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

Summary

The Clinical Trial Subject Matter Expert (CT SME) provides clinical expertise and advice regarding study protocols to a multi-disciplinary production team to enable the creation of various training modules for our clients. The CT SME reviews the training modules for 100% accuracy to the protocol and to ensure that it provides value to the end user.

**Responsibilities**:

- Accountable for determining the protocol-specific challenges for each protocol that has been assigned to the team and identify possible Firecrest solutions.
- Responsible for reporting to the Production Team at project start up to provide protocol information and background to aid in the teams understanding of the study.
- Required to provide support to the team PM at Client External Kick Off meetings.
- Responsible for supporting the team Technical Writer (TW) to produce Firecrest scripts that are 100% technically accurate for our site training modules.
- Responsible for the technical review of scripts prepared by other members of the team to ensure 100% technical accuracy to the protocol and relevance to the end user (i.e. Investigators and Site Staff).
- Takes ownership for the technical accuracy of all product graphics ensuring that they are both informative and 100% correct.
- Oversees the review of all modules prior to final release to the client to ensure that all quality standards have been met.
- Creates supporting documentation to compliment the end products to add value for the client.
- Accountable for the correct interpretation and implementation of client edits in our training modules.
- Supports the production team with clinical expertise and guidance as and where required.
- Required to attend team meetings and provide clinical expertise as needed on all study components.
- Expected to work closely with the team PM to ensure the delivery of an on-time and high quality product beneficial to those who work on the trial and ensuring maximum usage by the end user.
- As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
- Reports to Clinical Trial Advisory Manager, and/or other relevant departments, feedback from study teams, CRA’s and investigational site staff.
- Expected to ensure that all department responsibilities are maintained including but not limited to protocol security and internal databases.
- Responsible for providing clinical guidance when required to the sales team.

Skills required:
- Prior relevant experience in the clinical trials industry, preferably as a CRA.- Familiarity in working with clinical trial protocols (and other study documents), ideally across several therapeutic indications.- Excellent communication skills- Minimum of Bachelor’s degree or local equivalent

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

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.

We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.

But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON is an equal opportunity and inclusive employer and 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 s

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