Study Start Up Associate I

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.

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. You will be partnering with one of the worlds premier Biopharmaceutical companies. You will be responsible for leading or supporting operational activities from start-up to close-out, for assigned studies and investigator sites to ensure compliance with study timelines and in accordance with prevailing laws and Good Clinical Practices.

What you will be doing:

• Initiate and coordinate activities and essential documents management during start-up towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for site initiation
• Work directly and interact with investigator sites to confirm readiness for site start-up by reviewing study site profile ready in SIP or reviewing/completing critical information Sheet inclusive of but not limited to Investigator Initiation Packages (IIP) essential documents components, Site contracts contacts, clinical supply shipment information, payment information, IRB submission and status
• Perform timely and accurate task progress communication and data entry of all relevant study start up activities into the appropriate tracking system
• Coordination of all necessary translations required for any start-up documentation
• Attend study team meetings as required
• Coordinate, balance and facilitate activities related to the completion of Critical Document Package (CDP) and the IP release checklist (SST004-SOP-F01) in accordance with ICH GCP guidelines and all applicable regulations, laws, ethical standards, other guidelines, sponsor requirements
• Ensure that the overall process is focused on quality, efficiency and cost containment for a particular region / sub division within the CDP group, under the general mentorship of Mgr/Sr. Manager – Central Services or Designee

You are:

• A high school diploma or local equivalent
• Bachelor’s Degree preferably in Life Sciences
• Minimum of 2 years’ experience or understanding of clinical study start up requirements and activities
• Experience of Clinical Trial operations and meeting regulatory guidelines
• Proficient project management skills

• Ability to work independently and also as a team member and to organize tasks, time and priorities, ability to multi-task

• Excellent oral and written communication skills
• Proficient in German and English

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 maximise 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 website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsICON, including subsidiaries, 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, colour, 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.

#LI-SC3