Senior Local Operations Manager - Oncology

Senior Local Operations Manager - Oncology

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.

The Senior LOM role is a site aligned end-to-end partner to streamline communication across cross functional stakeholders throughout trial lifecycles.

The Senior LOM serves as the primary point of communication for sites, facilitating internal client teaming to drive issue resolution. They intimately understand the site operational model and own relationships with critical site stakeholders to provide a voice for the site to the client’s teams. They 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 reports and country feasibility reports. They collaborate with the central study team and local stakeholders as applicable for final selection of sites to participate in the trial.

They ensure the 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. They act as the primary company contact for assigned trial sites, engaging with Investigators and Site Staff throughout the life of the trial. They focus on investigator engagement through timely follow-up with sites and promptly communicate relevant status information and issues to appropriate stakeholders.

They drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress. When necessary they initiate corrective and preventive actions (CAPA) when the trial deviates from plans and communicate study progress and issues to study management teams and the Quality & Compliance team. They contribute to site-level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research targets. They deliver competent vendor management at the country level to support the study and may submit requests for vendor services and support vendor selection, including reviewing and approving site and local vendor invoices as required. As required, they manage the local study supply.

They ensure high standards for study monitoring by conducting quality local trial team meetings and facilitating SM training when needed, such as implementing study amendments and changes in study-related processes. They contribute to patient understanding of protocol and patient safety by preparing country-specific informed consent in accordance with procedural documents/templates, reviewing and managing site-specific informed consent forms in accordance with SOPs and applicable regulations. They ensure trial subject safety by reporting all adverse events (AEs)/serious adverse events (SAEs)/progression of questions/concerns (PQCs) within the required timelines and documenting as appropriate.

They ensure inspection readiness by maintaining complete, accurate and timely data and essential documents in systems used for trial management (e.g., CTMS and eTMF/IF) according to expectations and archiving retention requirements. When issues are identified or trends are noted from MVR review, they escalate deviation issues to the Trial Delivery Manager/Trial Delivery Lead and the sponsor in a timely manner. They are accountable for ensuring quality data (accurate, valid and complete) is provided by the site and queries are resolved within expected timelines.

They keep themselves inspection-ready and knowledgeable for current work by complying with relevant training requirements and developing therapeutic knowledge sufficient for role and responsibilities. With a focus on quality and compliance, they work closely with the Site Manager to ensure CAPA is implemented for audits/inspections or any quality-related visits, and may conduct accompanied site visits with the Site Manager if delegated by Sponsor. They ensure accurate finance reporting and that the trial is delivered within budget by adhering to finance reporting deliverables and timelines, including forecasting and proactive management of country/local trial budgets. If applicable, they may assist in negotiations of trial site contracts and budgets.

They keep 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. They may contribute as a trainer of systems/processes or provide input to the functional area in process initiatives, if applicable. They ensure full utilization of timely and accurate time reporting. They have experience in management and startup of complex Early Phase trials in coordination with internal matrix clinical teams and sites, as applicable. If applicable, region-specific deliverables will be specified. They have autonomy with execution of local trial management services and depth of knowledge with local trial management services, demonstrating process leadership.

What you need to have

• BA/BS degree.
• Degree in a health or science related field.
• 3 - 5+ years of trial end-to-end management experience.
• Start-up and database locks/cleaning experience preferred.
• 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, with good written and oral communication skills as appropriate.
• To qualify, applicants must be legally authorized to work in the United States and should not require sponsorship for employment visa status now or in the future.

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

At ICON, inclusion and 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.

If you need a reasonable accommodation for any part of the application process or to perform the essential functions of a position, please let us know.

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.