Study Start Up Associate I/ii/sr

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.

The Role:
As a member of the Study Start Up Team, you will play an integral role in making sure that physicians at our research sites are prepared to start the trial of investigational, new pharmaceutical and biological products for clinical trials at their local practices.

What you will be doing:

- Provide country-specific expertise in Study Start Up (SSU) to SSU team leads and project teams.
- Prepare and coordinate submissions to regulatory authorities, ethics committees, and other relevant bodies.
- Perform feasibility assessments, site identification, site contract negotiations, and other SSU activities.
- Develop, finalize, and review Master and Country-Specific Subject Information Sheets/Informed Consent Forms.
- Prepare Ethics Committee (EC) and regulatory submission packages according to the requirements of selected countries.
- Coordinate and facilitate the completion of the Critical Document Package (CDP) and the IP release checklist (SST004-SOP-F01) in line with ICH GCP guidelines, applicable regulations, laws, ethical standards, and sponsor requirements.
- Ensure that processes are focused on quality, efficiency, and cost-effectiveness for a specific region or subdivision within the CDP group, under the guidance of the Manager/Senior Manager - Central Services or their Designee.

Your Profile
- A Bachelor’s Degree or local equivalent and/or appropriate experience from the Medical/science background and/or discipline.
- A minimum of 1-3+ years of experience or understanding of clinical study start up requirement and activities.
- Experience of Clinical Trial operations and meeting regulatory guidelines
- Proficient project management skills
- Fluency in the local language and English is essential.

**Please submit Resume/CV in English**

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 status.

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