Senior Clinical Trial Manager

ICON plc • Blue Bell, SD

4d • Remote

About The Position

The Senior LOM role is a site aligned E2E partner to streamline communication across cross functional stakeholders throughout trial lifecycles. Serves as the primary point of communication for sites, facilitating internal client teaming to drive issue resolution. Intimately understands site operational model and owns relationships with critical site stakeholders to provide a voice for the site to the client's teams. Contribute to quality Site Selection through participation in site feasibility ensuring consistent conduct of site qualification visits and appropriate follow-up of site qualification visit report and country feasibility report. Collaborates with central study team and local stakeholders as applicable for final selection of sites to participate in trial. Ensures local/country team is meeting recruitment targets with high quality data on time and within study budget by providing input to study level documents and leading/coordinating local team activities in compliance with SOPs, other procedural documents and applicable regulations. This may require development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting. Act as primary company contact for assigned trial sites, engaging with Investigator and Site Staff throughout the life of the trial. Focuses on investigator engagement through timely follow up with sites. Promptly communicates relevant status information and issues to appropriate stakeholders Focuses on investigator engagement through timely follow up with sites. Promptly communicates relevant status information and issues to appropriate stakeholders Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress. When necessary initiates corrective and preventive actions (CAPA) when the trial deviates from plans and communicates study progress and issues to study management teams and Quality & Compliance team. Contribute to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target. Delivers competent vendor management at the country level to support the study and may submit requests for vendor services and support vendor selection. This includes reviewing and approving site and local vendor invoices as required. As required, manages the local study supply. Ensures high standards for study monitoring by conducting quality local trial team meetings and facilitating SM training, when needed (i.e. implementation of study amendment-and changes in study related processes). Contributes to patient understanding of protocol and patient safety by preparing country specific informed consent in accordance with procedural document/templates. This includes reviewing and managing site specific informed consent forms in accordance with SOPs, other procedural documents and applicable regulations. Ensures trial subject safety in that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented, as appropriate. Ensures Inspection readiness by maintaining complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. CTMS and eTMF/IF) according to expectations (metrics) and archiving retention requirements. When issues are identified or trends across a project are noted from MVR review, will escalate deviation issues to TDM/TDL and J&J Sponsor in timely manner. Accountable for ensuring quality data (accurate, valid and complete) is provided by the site and queries are resolved within expected timelines. Keeps oneself inspection ready and knowledgeable for current work by complying with relevant training requirements and developing therapeutic knowledge enough for role and responsibilities. With focus on quality and compliance, will work closely with SM to ensure CAPA is implemented for audits/inspections or any quality related visits. May conduct accompanied site visits with SM, if delegated by Sponsor. Ensure accurate finance reporting and trial delivered within budget by adhering to finance reporting deliverables and timelines. This includes forecasting and proactive management of country/local trial budget. If applicable, may assist in negotiation of trial site contracts and budgets. Keeps the trial in compliance with local regulatory requirements by organizing and ensuring IEC/HA approvals in cooperation with the local Start Up team, as applicable. May contribute as a trainer of systems/processes or provide input to functional area in process initiatives, if applicable. Full utilization by timely and accurate time reporting. Experience in management and startup of complex Early Phase trials projection with internal matrix clinical teams and sites, as applicable. If applicable, region specific deliverables will be specified. Autonomy with execution of local trial management services. Depth of knowledge with local trial management services. Process leadership.

Requirements

• BA/BS degree.
• Degree in a health or science related field.
• 3 - 5+ years of trial end to end management experience
• Solid Tumor Oncology experience required
• Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures.
• Strong IT skills in appropriate software and company systems
• Proficient in speaking and writing the country language and English.
• Good written and oral communication skills as appropriate
• Applicants must be legally authorized to work in the United States and should not require, now or in the future, sponsorship for employment visa status
• Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Nice To Haves

• Start-up & Database Locks/Cleaning experience preferred

Responsibilities

• Serve as the primary point of communication for sites, facilitating internal client teaming to drive issue resolution.
• Understand site operational model and own relationships with critical site stakeholders.
• Contribute to quality Site Selection through participation in site feasibility.
• Ensure consistent conduct of site qualification visits and appropriate follow-up.
• Collaborate with central study team and local stakeholders for site selection.
• Ensure local/country team meets recruitment targets with high quality data on time and within study budget.
• Develop local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.
• Act as primary company contact for assigned trial sites, engaging with Investigator and Site Staff.
• Focus on investigator engagement through timely follow-up with sites.
• Promptly communicate relevant status information and issues to appropriate stakeholders.
• Drive study compliance by maintaining and updating trial management systems.
• Initiate corrective and preventive actions (CAPA) when the trial deviates from plans.
• Communicate study progress and issues to study management teams and Quality & Compliance team.
• Contribute to site level recruitment strategy and contingency planning and implementation.
• Deliver competent vendor management at the country level.
• Review and approve site and local vendor invoices.
• Manage the local study supply.
• Ensure high standards for study monitoring by conducting quality local trial team meetings.
• Facilitate SM training when needed.
• Contribute to patient understanding of protocol and patient safety by preparing country specific informed consent.
• Review and manage site specific informed consent forms.
• Ensure trial subject safety by reporting AEs/SAEs/PQCs within required timelines.
• Ensure Inspection readiness by maintaining complete, accurate and timely data and essential documents in systems.
• Escalate deviation issues to TDM/TDL and J&J Sponsor in a timely manner.
• Ensure quality data is provided by the site and queries are resolved within expected timelines.
• Comply with relevant training requirements and develop therapeutic knowledge.
• Ensure CAPA is implemented for audits/inspections or any quality related visits.
• Conduct accompanied site visits with SM, if delegated by Sponsor.
• Ensure accurate finance reporting and trial delivered within budget.
• Forecast and proactively manage country/local trial budget.
• Assist in negotiation of trial site contracts and budgets.
• Keep the trial in compliance with local regulatory requirements by organizing and ensuring IEC/HA approvals.
• Contribute as a trainer of systems/processes or provide input to functional area in process initiatives.
• Ensure timely and accurate time reporting.
• Manage and startup complex Early Phase trials projection with internal matrix clinical teams and sites.

Benefits

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

What This Job Offers

• Job Type: Full-time
• Career Level: Senior