Senior Clinical Trial Manager

Senior Local Operations Manager - HemOnc - US

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

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.