Clinical Trial Manager

Clinical Trial Manager- 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:

Oversight of PASS study and supporting RMP relevant tasks

• Assures compliance with all protocol requirements; assures effective patient enrollment plan is in place.
• Assures timely reporting of Adverse Events (AEs)/Serious Adverse Events (SAEs) and protocol violations; accountability of study-related materials; regularly reviews the status of study status; maintain effective time management skills.
• Review and submission of periodic report to HA within due date.
• Manage study budget and outsourcing vendors' fee or study-related fees timely.
• Managment of study stutus and timeline
• Attend medical staff meetings, project team meetings, teleconference with oversea colleagues, and internal or external clinical training session according to the project communication, training plans.
• Maintains timely and effective communication among cross-functional team members and CROs if necessary, site staffs.
• Support local RMP preparation including RMP's mandated studies; participates local RMP implementation meeting if applicable, and shares

PASS activity status  with relevant relevant functions internally.

• Shares PASS activities with HQ and required parties (sharing AE reporting cases, periodic report submission status, any issue findings, local PASS relevant regulations. etc)

Oversight of CRO

• Selection and contract outsourcing vendors
• Management and oversight of CRO tasks for following the regulations and SOP
• Responsible for CRO management: monitors all types of PASS studies; if needed, may participate in all types of site visits with CROs.
• Manages with the preparation of study start-up materials and tools with CROs, as requested.
• Manages essential documents (protocols, ICF, and CRFs. etc) preparation and review process with CROs and headquarter if requested; may amend essential documents based on  regional office or  company's comments, well-communicated with regional project leader.
• Control of PASS related issues

Others

• Review and revise local PV SOP; Monitoring PASS related local regulations and cope with the new trend with innovative mindset
• Training internal and external staffs; Preparation of training materials
• If requested, back-up handling of ICSRs (if requested, SUSARs reporting, AE training back-up, product based request from HA or HQ, reconciliation between safety database and clinical database, safety reporting plan review, etc)

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You are:

• Minimum 7 years of project management experience in PMS or phase IV studies in CRO/Pharma inducstry
• Must have full cycle experience (mandatory)
• Understanding local  PASS related regulations and SOPs  and application on  study
• Experience on  PASS study (Understanding of Protocol, CRF, ICF, medical records, data management, statistics)
• Knowledge for  company's products and overall knowledge for  other medications
• Abilities to identify potential issues and implement corrective actions independently
• Proactive, Interpersonal, decision-making and issue resolution skills are required
• Abilities for  communication with internal and external staffs of company

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/benefits

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. 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 through the form below.

https://careers.iconplc.com/reasonable-accommodations

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.