Study Start Up Associate w Warszawa, Polska

Pol-HB- SSUA

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

As a Study Start Up Associate I at ICON, you will support the operational aspects of all clinical trial submissions made under the Global/Local Clinical Trial Regulation per EU CTR, in the Clinical Trial Information System (CTIS), for internally managed trials. SSUA I will work in support of the Clinical Trial Submission Coordinator (CTSC), Regulatory SM and country teams to make all clinical trial initial submissions, clinical trial amendment submissions and clinical trial notifications in CTIS and track the progress of submissions/notifications.

What You Will Do:

Responsibilities include but are not limited to generation of progress tracking reports, analysis and follow-up, system data entry, setting up meetings and maintaining minutes, document management and transfer into CTIS, as relevant for initial submissions, substantial amendments and notifications for assigned clinical trials.

Deliverables:

·Services rendered will adhere to applicable SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc.

·Assist in study specific submissions document management and document collation for submission.

·Perform document quality and completeness checks.

·Transfer submission package to CTIS, make submission in CTIS and perform submission archiving.

·Ensure the current submission status and tracking of related information is always available in the appropriate clinical trial management system(s) (CTMS). Work with CTSC, Clinical Trial Managers and CRAs, Local Submission Coordinator, CRO to ensure submissions data are up-to-date, complete, and accurate during all phases of the trial.

·Support submission coordination activities and tracking of submission timelines and deliverables to ensure trial delivery according to agreed upon timelines/milestones.

·Responsible for review/management of CTIS for completeness and timely entry of information into CTIS.

·Support running relevant dashboards & metrics reports with option to provide status analysis.

· Coordinate and participate in study specific meetings, as necessary, and document outcomes, actions, and decisions. Follow-up to resolution when required.

·Maintain key trial specific information in CTIS.

·Perform relevant quality oversight and inspection readiness activities as necessary.

·Provide overview of submission/substantial amendment/notification management metrics as needed.

Your Profile:

You will bring relevant site start-up and activation experience, along with the following qualifications and skills.

• Bachelor's degree in life sciences or a related field.
• Previous experience in start up (submission area on local level) min. 1 year
• Strong attention to detail and organizational skills.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
• Ability to work independently and manage multiple tasks simultaneously in a fast-paced environment.

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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 maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.

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

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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.

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.

Are you a current ICON Employee? Please click here to apply