PMS Clinical Trial Manager

PMS Cinical Trial Manager - South Korea - Home based

You will be joining one of the global healthcare leaders that has been discovering and developing medicines and treatments for well over a century. You will be part of a global team that is committed to make life better for people around the world. We share a vision of bringing treatment and medicine to millions alongside develop healthcare knowledge and improve live.

You will be joining one of the global healthcare leaders that has been discovering and developing medicines and treatments for well over a century. You will be part of a global team that is committed to make life better for people around the world. We share a vision of bringing treatment and medicine to millions alongside develop healthcare knowledge and improve live.

What you will be doing:

1. Clinical Investigator Management

• Accountable for activities required at clinical trial sites and by investigators and site staff participating in company trials; inclusive of site identification and qualification, enrollment planning and execution, to database lock and close out
• Accountable for comprehensive investigator management activities to ensure timely delivery of enrollment readiness, trial recruitment/enrollment and database locks; inclusive of performance management and issue mitigation, identification and resolution
• Responsible for identifying potential opportunities to accelerate trial enrollment, while driving to an unparalleled clinical trial/customer experience
•  Accountable for the application of scientific, therapeutic area, and institutional/regional expertise to inform and ensure timely delivery of trial enrollment and quality data
• Accountable for the development of strategic institutional/site relationships to optimize the delivery of clinical trial programs; including across therapeutic areas where applicable

2. Clinical Trial Management

• Responsible for the development and implementation of applicable investigator / site risk plans to ensure delivery of clinical trial enrollment commitments and database locks
• Ensure site and country level inspection readiness at all times
• Leverage metrics to inform site/country/regional level decision making
• Work with internal and external teams to remove barriers to trial execution at a site and/or  country level
• Responsible for understanding local treatment paradigms and standard of care  to support targeted feasibility and strategic allocation of trials as required
• Provide vendor  oversight for site monitoring activities at site/country level
• For countries with PMS requirements: Responsible for Post-Marketing Safety Study management including CRO selection, Regulatory Document Development, and Project Management in compliance with local requirement as required.

3. Business Management and Engagement

• Establishes and develops strong professional relationships with active/potential clinical investigators to expand/maintain clinical research partnership opportunities and provide an unparalleled experience for participation in company clinical trials.
• Cross functional collaboration and partnership to ensure alignment in priorities and deliver the portfolio
• Perform targeted sites prospecting in alignment with portfolio strategy & priority
• Maintain therapeutic and technical expertise to enable scientific discussions with the investigator and site personnel
• Serve as an effective communication “bridge” between sites, third party vendors and company
• Influence and challenge internal and external factors in order to improve clinical research delivery

4. Country / Regulatory (where  required in countries where  Associate Director / Director Investigator Engagement is not located)

• Influence and engage with Regulatory bodies, Ethical Review Boards and other National Authorities to represent company
• Investigator Engagement in the country Clinical Trial environment(s).
•  Engage and influence within Country Pharmaceutical Associations / Affiliated bodies.
• Ensure internal processes and procedures are maintained to reflect and comply with country requirements. Share with other functions as appropriate and ensure local procedures are maintaine
• Engage in the external clinical development community to influence improvements, and drive the incorporation of learnings into internal improvement efforts and strategy
• Engage with affiliate leadership in support of the Associate Director / Director Investigator Engagement to ensure implementation of affiliate and regional initiatives

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You are:

• Bachelor’s degree or equivalent
• Minimum of 8 years experience in the pharmaceutical industry and/or clinical research and strong working knowledge of Good Clinical  Practice
• Therapeutic expertise and knowledge of the clinical research landscape; ability to acquire and maintain therapeutic expertise to support portfolio needs
• Strong  self-management and organizational skills; ability to manage workload, set personal priorities and adjust as needed
• Demonstrated strategic agility & broad  business acumen
• Demonstrated leadership behaviors with ability to accept challenges, seek opportunities to remove barriers, influence without authority, and lead in areas of uncertainty

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, inclusion & belonging are fundamental to our culture and values. 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, 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 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.