Study Start-up Project Manager

Study Start-Up Project Manager, Home-Based, South Korea

You will be partnering with one of the worlds premier Biopharmaceutical companies. Working across a vast portfolio of medicines and vaccines this company has, over centuries created a strong heritage of delivering innovative treatments and preventive medicines globally

What you will be doing:

• Responsible for delivering site activations to plan, This can be for all sites for an entire study or a portion of sites in specific countries in one or more regions.
• As part of the responsibility of delivering site activations to plan she/he will co-ordinate with many different roles working at the study and country level to oversee progress of the study specific (e.g. Vendor set-up, investigational product supply etc.) or country specific tasks (e.g. Regulatory submissions, importer of record for supplies etc.) that need to be completed in order for site activations in turn to complete.
• Provide project management of activities directly required to complete all site activations for an assigned study as part of a study management led team to complete all start up activities for a study.
• Lead start up meetings that facilitate alignment of site selection to activation activities performed by country level start up roles with the endorsed trial optimization plan (by senior leadership). Start up meetings use the ongoing risk assessment of site activation delivery to form a focused agenda according to risk level, the overall goal is the delivery of major study milestones to plan (e.g. first subject first visit) as well as the overall delivery of major site activations to plan (25%, 50% and 90% of planned site activations)
• She/He will work with country level start up roles to seek opportunities to accelerate site activations for their study, they will do so while considering the relative priority of their study compared to all concurrent studies in start up that country level start up roles are working on.
• Act as a key point of escalations for site activation related issues raised by country level start up roles, seeking to firstly resolve issues directly or triage appropriately to other on the study or the study management team, will always follow through to resolution.
• Responsible for the completeness and quality of site activation timeline plans for every site from investigator initiation package sent for first site in study, to site activation complete for last site in Will work with and drive all timeline plan owners (e.g. country start up roles) to actively manage the site activation timeline plans for their assigned sites. She/He will have a detailed understanding of the timeline for every site:
  • Understanding the critical path activities for all sites based on specific needs of every site and their associated upstream country and study related tasks
  • Plan and execute the timely delivery of the investigator initiation package needed for investigational product release to site in partnership with document owners (particular country level roles), including incorporating the translation requirements into that plan.
  • Work in lock step with specialist roles that work directly with sites on the study budgets and contracts to bring this key activity off the site activation critical path
  • Co-ordinate across all roles that work directly with site staff to complete site activation readiness tasks (system access and training, protocol related training) to time completion prior to the site initiation visit, or as soon as possible afterwards to reduce or eliminate from the site activation critical path  
  • Work across roles responsible for the delivery of all physical supplies (investigational product and all non-clinical supplies) to plan and execute delivery to all sites in lock step with all other tasks required for site activation

• Identify improvements and efficiencies to site activation processes and share lessons learned broadly with key stakeholders

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You are:

• Extensive global start up clinical trial/study management experience
• Comprehensive working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations
• A scientific or technical degree is preferred along with extensive knowledge of clinical trial methodology
• +5 years relevant experience
• + 2 year start up lead experience

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

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 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.