Study Start-up Associate

Study Start-up Associate - Homebased- South Korea

You will play a vital client facing line management role, embedded in our clients business. You will be responsible for the management of day to day clinical trial quality activities, ensuring everyone is well-trained on ICON standard processes, and promoting efficiency, quality, and timeliness in project work.

You will be partnering with a well-known global pharmaceutical company with a strong portfolio in cancer, cardiovascular, gastrointestinal, infection, neuroscience, respiratory and inflammation medicines.

You will have an opportunity to work in a solid partnership and an environment driven by innovation and continuous improvement. This program is for you if you are looking for an environment where people feel they belong and are empowered to reach their full potential, perform at their best and make a valued contribution to saving lives.

What you will be doing:

• Contribute to ensure that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
• Accountable for study start-up and regulatory maintenance being in charge with collection, preparation, review and tracking of documents for the application process;
• Accountable for submission of proper application/documents to IEC/IRB during start-up period.
• Actively participates in Local Study Team (LST) meetings.
• Update CTMS and other systems with data from study sites as per required timelines during the start-up period.
• Follow up on outstanding actions with study sites during start-up period to ensure resolution in a timely manner.
• Ensure timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Company SOPs and local requirements. Support QC checks performed by CTM or delegate to ensure that all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol, and in line with Company SOPs.
• Provide regular information to Line Managers at country level on study and planned study milestones/key issues during the start-up period.
• Provide feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.
• Support SMM in different initiatives (local, regional or global) as agreed with the SMM Line Management.

Upon local decision, additional responsibilities may include*:

• Prepare, review and negotiate contracts with investigational sites being the primary point of contact for investigational sites to ensure the contracts are fully executed  
• Support site selection process by identifying and assessing potential sites/investigators
• Accountable for continuing submission of proper application/documents to IEC/IRB for the duration of the study.
• Assist in initial forecasting for budget, study materials and drug supplies. Plan applicable local drug activities (local purchase or reimbursement)

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You are:

• Strong knowledge in ICH-GCP
• Ability to review and evaluate clinical data
• Computer literacy desirable
• Professional use of the English language; both written and oral
• Good oral and written communication skills
• Due to the nature of this position it may be required for the employee to travel
• +1.5 year SSU experience inculding with IRB Initial Submission, Contract/Budget Negotiation & Site Selection Visit etc
• Home-based

Why ICON?

At ICON, we embrace new perspectives and empower our people to write their own paths forward. We are a culturally diverse company with over 40,000 talented and ambitious people with varied skills, perspectives & backgrounds working together across 40 countries.

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.

At 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.

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.