Experienced Study Start Up Associate, German and English speaking, EMEA

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.

Study Start Up Associate II

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.

The Role

• Prepare Country template of Subject Information Sheets (SIS) and Informed Consent Forms (ICF).
• Prepare and submit study submission package to Ethics Committee (EC) and MoH. Including response to queries.
• Prepare and submit maintenance submissions.
• Effective interaction with Ethics Committees, MoH and sites to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct (start up and maintenance as assigned).
• Forecast submission/approval timelines and ensure they are achieved; provide risk and contingency plans to mitigate impact if forecasted timelines are at risk, and escalate issues as soon as identified.
• Prepare and submit Critical Document Package (CDP).
• Review and negotiate clinical site investigator contracts and budgets.
• Stay connected with Investigative sites, sponsors and internal personnel regarding the status of contracts and contract-related documents
  
   

What you need

• A bachelor's degree in Science, or related experience is preferred
• Previous experience in a similar role
• Experience in a clinical research environment within a CRO
• Strong command of English language and local language

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.

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