Job title: Associate Project Manager

Working location: Taipei, Taiwan, Client office based

Providing innovative solutions for our clients is what we do. But innovation just for the sake of innovation isn’t why we do it. Side-by-side with our clients, we strive to move drug discovery forward, to help them develop life-saving and life-improving drugs. We help change people’s lives for the better every single day. It’s who we are. And it’s who you could be too.

The job holder plan, initiate, conduct and manage global/regional/local medical & scientific affairs studies (including Local Data Generation (LDG), HECON, Post Approval Studies/Researches, Sponsor Investigator Studies Program and In Scope Research Types (interventional or non-interventional)) in compliance with regulations and company SOPs and Policy.

Responsibilities include, but are not limited to:

1. Design and/or implement a series of local/regional/global planned LDGs, HECON, and Post Approval Studies/Researches with customers
   • Work closely with internal (Medical Advisors, Medical Scientific Liaison, Pharmacovigilance, Legal, Compliance, Finance and Sourcing and Procurement Lead) & external stakeholders (Scientific Leaders, Health Care Provider, hospital official/administrative, vendor, 3rd party vendor, etc.) to implement and track the GMSA studies timely with quality, within budget and compliant.
   • Ensure GMSA studies design & implementation aligned with company Policy/SOPs and local regulation, GMSA MAP and strategy,
   • Plan and evaluate study timeline, fair market value, budget and all resource required,
   • Ensure Value Evidence Activity Portfolio (VEAP) data is updated and maintained throughout the study phase.
   • Communicate with study related team regarding budget allocation and executive plan,
   • Generate site feasibility questionnaire and conduct site feasibility visit to enroll qualified sites,
   • Generate start-up plan to ensure GMSA study can be initiated according to planned timeline,
   • Prepare IRB and TFDA study submission dossier (initial submission to close-out) and application,
   • Negotiate contracts and budget with investigators, hospitals and 3rd party vendor/vendor
2. Design and/or implement a series of local/regional planned Sponsor Investigator Studies Program (MISP) and In Scope Research Types (interventional or non-interventional) with customers.
3. Manage GMSA studies and sites to ensure studies can be conducted in compliance with regulations, SOP within timeline and budget
4. Maintain good relationship with site personnel,
5. Involve or/and conduct audit, inspections and other quality assurance activities,
6. Provide recommendation for continuous improvement, risk management control and knowledge transfer of Medical Scientific Affairs Projects within the company,
7. Contribute to Medical Scientific Affaires Operational excellence.
8. Design and/or execute the GMSA studies in compliance to sponsor’s policy/SOPs/ERs/WIs as appropriate and meet the ethics guidelines.
9. Timely track the publication status of GMSA studies (submission time, acceptance/rejection, conference, journal). Publication includes conference poster, abstract, oral presentation and manuscript published in peer-reviewed journal.

You are:

• MS degree in pharmacy or related health/medicine science.
• Strong project management skills and sense of urgency
• Have ability to deal with ambiguity
• Clinical study execution related knowledge, including but not limited to GCP, GPP, IRB submission, TFDA submission, site initiation/close out, site management, liaise with vendors, budget planning/management, study drug import, specimen export, etc.
• Proficiency in written and spoken English and local language. The incumbent must be competent and effective in written and verbal communication.
• Effective communication
• Good problem-solving skills
• A good teamwork player with responsible working attitude
• At least 5 years of Clinical Research Associate (CRA) or clinical project management experience or related equivalence

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.