Clinical Trial Manager

Study Start-up Manager-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 manage clinical trial operations activities, supporting your team and stakeholders to deliver high-quality outcomes across our clinical programmes.

What You Will Do:

Job purpose

Study Start Up Clinical Study Manager (SSU CSM) is accountable for the day to day planning, executing and reporting (from country feasibility up to and including site initiation), of assigned innovative medicines phase I-IV studies in compliance with Novartis processes and regulatory requirements. The CSM is the single point of contact and local study team lead, within the country/ cluster and responsible for assuring aligned communication with country/ cluster CRA, CRA managers and other key country associates.

Trial Monitoring strategy

• In collaboration with the Trial Monitoring key stakeholders (CSM Group Head, Regional Operations Manager (ROM), local/global medical, Trial Operations Manager (TOM), and global clinical assists in the development of local study execution plans and timeline commitments for a Country/Cluster
• Participates in the development of innovative solutions for site and patient participation to ensure the delivery of assigned studies on time

Allocation, initiation and conduct of trials

• Supports study feasibility and country patient commitments in collaboration with Country/Cluster Trial Monitoring and Medical. Collects and manages input to the study protocol, and operational aspects of the study
• Leads site selection in collaboration with Country/Cluster Trial Monitoring and Medical
• Ensures that study start-up activities are conducted and completed on time, including preparation of IRB/EC submission packages, review of Informed Consent Forms, engaging Regulatory Affairs/CTA Hub for Health Authorities submissions, as required, in collaboration with Country/Cluster Trial Monitoring stakeholders
• Works with local Drug Supply Management, aligned with BPA, to forecast local IMP and comparator needs as appropriate. Ensures IMP is available to commence and complete assigned trial/assigned trial sites
• Oversees local vendor selection and performance as needed. Serves as main contact for quality/compliance issues, escalating as necessary
• Ensures sites are prepared for “Ready to Initiate Site” (checkpoint), inclusive of written confirmation, and ensures all documentation is in place for initial and subsequent drug release in collaboration with the local Qualified Person(s)
• Maintains a strong knowledge of the study protocol to answer standard operational questions from CRAs, sites, and internal Country/Cluster personnel
• Drives the conduct of the study, (tracks status, maintains study level reporting systems, oversees forecasts, progress, and mitigation plans), to ensure all study operational aspects are on track
• Ensures recruitment targets are met and reviews enrolment at the site level including responsibility for approval of enrolling above site targets. Is responsible to set up contingency plan to ensure recruitment targets are achieved in accordance with trial execution plan
• Oversees local clinical team activities to achieve study timelines and quality execution, (proposing and implementing corrective actions where appropriate), according to Novartis standards and local and international regulations
• Leads/chairs local study team meetings or supports Sr. CSM in the conduct of local study team meetings, participates in global clinical trial team meetings, as required and is the single point of contact for the conduct of assigned studies or study sites
• Coordinates the study handover process with the CRAs and their managers to ensure proper documentation and communication, when necessary

Delivery of quality data and compliance to quality standards

• Conducts or coordinates training, as needed, for CRAs to support site readiness to recruit and study execution ensuring adherence to clinical data standards, prevailing legislation, GCP, Ethical Committee and SOP requirements
• Conducts or coordinates local investigator meetings as needed
• Ensures documentation of training (global/regional/local investigator meeting minutes, participants’ lists, certificates, etc.) is archived in the Trial Master File
• Evaluates potential challenges/risks within the protocol and operational aspects of the study; assessing impacts, developing risk management plans and communicating/ escalating to regions and/or global teams, as appropriate

Budget and productivity

• Monitors the status of site budget and contract negotiations as well as the collection and review of essential documents throughout study start up under the direction of their manager
• Tracks study budget with appropriate study budget responsible in Country/Cluster. Ensures timely TCF preparation and submission in collaboration with the TCF specialist in the Country/Cluster
• Processes invoiceable items for site level clinical study activities to allow timely payments

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:

• University degree in medicine, science, or equivalent combination of education & experience
• Demonstrated ability to drive the clinical deliverables of a study
• Subject matter expertise in the designated therapeutic area
• Prior monitoring experience is preferred
• Willingness to travel as required (approximately 25%)

#LI-remote

#LI-SO1

What ICON can offer you:

Visit our careers site to read more about the benefits ICON offers.

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, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Are you a current ICON Employee? Please click here to apply