Study Start Up Associate

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.

Required qualifications and experience:

• 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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Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

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

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

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