Project Manager, Home-based, South Korea
As a (Project Manager) you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
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 management/oversight of study and regional/country level activities from study startup through conduct and study close
- May manage the study start up process in countries assigned (where SUPM not assigned) and/or oversee CRO responsible for these activities as applicable
- Site identification and feasibility ensuring countries/sites can meet all study protocol requirements
- Provides country level input on Startup and Recruitment milestones as provided by CRO and/or Country Trial Manager to Global Study Manager during planning
- Is accountable for overseeing CRO and/or Country Trial Manager for assigned studies at country level in accordance with the overall project plan, manages and maintains accurate country level plans (e.g. timelines, budget, risk and quality plans)
- Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution and implements mitigation strategies as required. Is also accountable for resolution of Site Activation escalations to Study Teams including offering options for mitigation
- Leader of the Local Study Team (core members: (Lead) Site Care Partners Clinical Trial Assistant, ad hoc members: ICL, Site Activation Partner, CTRO and Local Regulatory, Medical Affairs colleagues and other key stakeholders as required)
- Ensures compliance to relevant Global and Local, internal and external requirements and regulations
- Ensures timely communication bidirectionally between the global and local study team.
- Provides protocol level guidance and support to responsible Local Study Team members as applicable.
- Utilizes roles in country such as Lead Site Care Partner, and expert roles such as Contracts Leads, Site Activation Partners to provide the Global Teams with local intelligence and operational nuances to be considered
- Acts as the study level point of contact for all study-level questions for the Local Study Team, ensuring resolution at lowest possible level, and when needed liaising with and escalating to appropriate global roles/teams
- Follows up on region/country level issue status to ensure resolution.
- Identifies country level trends to improve deliverables processes as needed
- Utilizes country intelligence to provide input on country specific risks into preparation of Investigational Quality Management Plan, Study Monitoring Plans, ensures PTMF completeness and oversight of all relevant compliance activities for allocated studies
- Ensures audit/Inspection readiness during start-up and conduct
- Manages applicable Quality Events with CRO and local team as applicable and required
- Coordinates effective site recruitment planning to allow for implementation of plans at the country and site level, consistent with global plan and local targets
- Responsible to drive and ensure delivery of data cleaning deliverables for CRO and sites as applicable
- Provides input on Country level Per Subject Costs, local vendor costs and other fees where applicable
- May act as a Subject Matter Expert
- May lead operational effectiveness initiatives at country or regional level
- Responsible for PTA and SIV report review for reports completed by the Site Care Partner
- Supports implementation of Pfizer's Site Technology Experience systems (e.g. Shared Investigator Platform SIP, Centralized Account Management CAM)
- Support to EC/RA and other relevant (e.g. radiation, biobank) submissions and deficiency/query responses for initial and subsequent CTA submissions within required timelines
- Drives CRO and/or applicable internal study team members to ensure PTMF set up meets study requirements, and maintains oversight of PTMF completeness
- Provides country level documents to PTMF and maintains oversight of Investigator Site File (ISF) reconciliation and completeness actions
- Ensures CRO and/or applicable internal study team members maintain appropriate level IP/equipment/ancillary supplies management including Import/Export License management with the support of Clinical Trial Assistants and other roles as required
- Supports implementation of new tools and technologies (e.g. eConsent, eISF, Remote Source Access, remote SDV/SDR, iConnect, implementation of protocol required decentralized trial options etc.)
- Support Identification, contract development and management of local vendors or facilities as per protocol
- Investigator Meeting support and management including doing presentations as appropriate
- Management of local Investigator Meetings including doing presentations as appropriate
#LI-remote
#LI-SO1
You are:
- Relevant operational clinical trial experience
- A scientific or technical degree is preferred along with knowledge of clinical trial methodology
- 3~5+ years of relevant experience in BS/BSc/MS/MSc
- Working knowledge of Good Clinical Practice, clinical and regulatory operations and environment in countries under responsibility
- English is required.
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.
.jpg)
.jpg)
