CTM PMS- 1year contract-Home based-South Korea-ICON Strategic Solutions
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
As a Clinical Trial Manager at ICON, you will oversee the planning and execution of clinical trials, ensuring that they are conducted efficiently and in compliance with regulatory standards.
What You Will Do:
You will manage day-to-day clinical trial management activities, supporting your team to deliver quality outcomes.
Key responsibilities include:
General
• Serves as the primary point of contact for clinical operations on assigned projects.
• Oversees clinical deliverables including site selection, subject/patient recruitment, monitoring and data collection and handling, to meet quality, regulatory and timelines expectations. Ensures compliance with protocols, GCP, SOPs, and clinical budget requirements.
• Drives adherence to all project, program and site delivery plans
• Drives enrollment strategies and proactively address risks to study timelines.
• Responsible for the development maintenance, and Delivery of operational plans e.g. for clinical deliverables CRF completion guideline, Monitoring Plan, Clinical Management Plan (CMP), Study- and Site-specific Recruitment Plan, Clinical Training plan, Protocol Deviation Guidelines, annotated trip report etc.
• Recognizes, exemplifies and adheres to ICON's values.
• Leads by example and motivates all assigned team members.
• Actively identifies opportunities for process improvement. Leads or participates in process improvement initiatives, as assigned, and promotes the sharing of best practices. Recognizes the importance of, and creates a culture of, process improvement with a focus on streamlining our processes, adding value to our business, and meeting client needs.
• Sets expectations for the clinical study team and drives a performance culture through their teams.
• Establishes a culture of engagement within each project team, increasing team connection, a sense of ownership and increasing retention
• Establishes approach and leads Clinical Operations resources to achieve operational and strategic project plans.
• Ensures that quality standards and applicable regulatory requirements are met. Collaborates with quality assurance department members to identify study sites requiring corrective and preventative action plans.
• Ensures client satisfaction regarding delivery of the clinical portion of the project in line with the study contract
• Maintains confidentiality of information, as appropriate.
Project Operations
• May work on multinational studies, collaborates with a cross functional teams, vendors and sponsors to ensure successful project delivery.
• Leads clinical team meetings and represent clinical operations in internal and external meetings.
• Maintains accurate and timely data entry in CTMS and other systems.
• Oversees essential document filing and ensures inspection readiness.
• Independently manages delivery of non-complex clinical studies, i.e. low risk, small budget or geographic scope, low number of sites or assists with management of complex studies. May be assigned to a more complex trial with support of a larger CTM team.
• Leads clinical resources in a matrix environment, as required.
• Recognizes potential risks within the study protocol and operational aspects of the trial; serves as the primary liaison for clinical monitoring, site risks and issues; proactively establishes contingency and mitigation plans. Analyzes metrics and reports to keep abreast of performance. Leverages plans to address issues.
• Sets and communicates expectations, clear goals and objectives for the study(ies) to clinical team members and drives a performance culture.
• Communicates effectively with client, vendors, project manager, functional team leads and other project team members; leads clinical team meetings and presents clinical topics at cross-functional internal and external meetings, as appropriate.
• Escalates appropriately when not able to solve issues or when potential risks may have a wider impact
• Actively addresses and ensures clinical data is entered into the CTMS in a timely and accurate manner.
• Responsible for proactively driving enrollment as per contracted timelines.
• Ensures all clinical closeout activities are completed as necessary e.g all payments made, CTMS updated, all visit reports finalized, and all action items resolved.
Project Governance
• Monitor clinical metrics and performance indicators such as visit report timelines, action item resolution, and site compliance.
• Identifies potential risks and implements mitigation strategies proactively.
• Supports internal audits and health authority inspections, ensuring corrective and preventive action plans are implemented as needed.
• Continuous oversight of key clinical metrics, including but not limited to: Days on Site (DOS), Monitoring Visit reports (MVR), Confirmation (CL) and Follow up Letters (FUL) timelines, Action items (Al) and other quality metrics, to ensure they are met and followed up as necessary.
• Oversight of visit report review and approval, including site issue escalation and resolution. This may involve direct review/approval of site visit reports and interacting with the Central Visit Report Reviewers and Approvers, as appropriate.
Project Finance
• Manages clinical budgets and forecasts, ensuring alignment with contractual obligations.
• Reviews and approves investigator grants and escalate out-of-scope tasks as appropriate.
• Maintains thorough knowledge of contract details; escalates out-of-scope clinical tasks for review and approval prior to execution.
• Responsible for analyzing, planning, forecasting, scheduling, and implementing the clinical aspects of projects in line with contract and budget, e.g., implementation of protocol and amendments; protocol deviation prevention, tracking and reporting; IP management, timely investigator payments.
• Able to identify clinical project risks and communicate potential financial impact.
Resourcing
• Works closely with resourcing teams to ensure adequate staffing for all clinical activities.
• Leads and mentors clinical project team to ensure high performance and accountability.
• Develops and implements training plans for clinical teams and study sites.
• Monitors team performance against project metrics, providing feedback and escalating issues when necessary.
• Fosters a culture of quality, collaboration, and continuous improvement.
• Develops and manages a succession plan for clinical study team members and, in the event of a change to the team, ensures an effective hand-over that is appropriately documented.
RFP/Project Budget
• Participates in business development activities including bid defense meetings; may be required to provide input to the clinical strategy.
Commercial Success
• Participates in Company/Departmental initiatives, as requested, to ensure ICON’s continued success.
Other
• May travel (approximately 20%) domestic and/or international
Your Profile:
You will have solid clinical trial management experience, with the ability to manage competing priorities and develop your team.
Required qualifications and experience:
- Degree in life sciences, clinical research, or a related field.
- Significant experience in clinical trial management, with a proven track record of leading successful trials.
- Strong understanding of regulatory requirements and GCP in clinical research.
- Excellent leadership and communication skills, with the ability to motivate and manage cross-functional teams.
- Proven analytical and problem-solving skills, capable of navigating complex project challenges.
- Willingness to travel as required (approximately 25%)
- 1 year fixed term contract position
- +7 yrs PMS study experience
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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 maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.
