Study Start Up Associate I

As a Study Start Up Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

The SSUA supports the operational aspects of all clinical trial submissions made under the Global/Local Clinical Trial Regulation pe EU CTR, in the Clinical Trial Information System (CTIS), for internally managed trials.

What you will be doing:

• Services rendered will adhere to applicable client  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 Manager, CRA, country Local Submission Coordinator, CRO to ensure submissions data are upto-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.
• Assist CTSC, Regulatory CTA, CRA, CTM and GTL with applicable CTIS support.
• Provide overview of submission/substantial amendment/notification management metrics as needed.
• Other activities as delegated by the CTSC or assigned by Functional Manager. 
• Participate in global and regional improvement initiatives, as assigned.

You are:

• BA/BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience).

• 1-2 years of relevant clinical trial experience with associated skill sets.

• Excellent organization skills, excellent written and verbal communication skills.

• Excellent independent time management skills.

• Proven ability to plan and track deliverables and timelines.

• Ability to work well in a dynamic environment and able to prioritize and respond to changing needs of the business.

• Proficient Microsoft Office applications and use of Internet, EXCEL, POWERPOINT, WORD.

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, 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.

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.