Lead Local Operations Manager - Solid Tumor Oncology
Listed on 2026-07-13
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Management
Regulatory Compliance Specialist, Operations Management, Program / Project Manager
Location: Spring House
Lead Local Operations Manager – Solid Tumor Oncology
The Lead Local Operations Manager (LOM) is a senior operational leader accountable for US country level site performance, operational strategy, and delivery across the end-to-end clinical trial lifecycle. The Lead LOM serves as the US operational nexus for assigned trials, coordinating Local Operations Managers, resolving complex escalations, and integrating country level operational insights into global trial planning and execution.
Operating as a player coach, the Lead LOM leads and mentors other Local Operations Managers while directly managing strategic or high impact sites and programs. The role ensures strong alignment between site level execution and global trial objectives, driving delivery against key operational KPIs related to feasibility, startup, enrollment, data quality, compliance, and closeout.
Compared with Associate and Senior Local Operations Manager roles, the Lead LOM is typically assigned to key USA Oncology sites, more complex trials, programs, or portfolios, may work across multiple disease areas, and is expected to exercise advanced judgment, influence, and leadership to ensure successful country level trial delivery. The Lead LOM may represent the country's performance for a specific trial, in global trial forums and may, where required, assume broader trial delivery leadership responsibilities in accordance with Global Development procedural documents.
You will be responsible for:
- Owns US site level operational delivery for assigned sites
- Leads and coordinates local trial team activities in compliance with SOPs, other procedural documents, and applicable regulations.
- Leads local project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget, including but not limited to: development of local trials specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting. Provides leadership oversight and mentoring support to other local operations managers assigned to the trial or program
- Shapes US trial operational strategy and integrates site insights into global feasibility and startup planning.
- Serves as the primary US operational interface to global trial leadership.
- Monitors country level operational KPIs and identifies systemic risks and mitigation strategies.
- Acts as escalation point for complex site contracting, operational, and recruitment issues.
- Represents US local operations at investigator and/or study coordinator site meetings and key governance forums.
- Acts as subject matter expert for assigned protocols and develops strong therapeutic knowledge to support roles and responsibilities. May represent Oncology Site Enablement on cross functional teams.
- Elevates US site insights to inform global decision-making and continuous improvement.
- 10% travel is expected.
- Expected to assume additional responsibilities or special initiatives such as "Champion" or "Subject Matter Expert" and to represent the functional area or lead country, Delivery Unit, and global level process initiatives, as required.
Qualifications / Requirements:
- A minimum of a bachelor's degree in Life Sciences, Nursing, Pharmacy, or related scientific discipline (or equivalent experience) is required; advanced scientific or clinical degrees are an advantage.
- Typically, a minimum of 4 years of experience in clinical trial operations, trial management, site management, or clinical monitoring, including significant experience in complex, high-priority, or multi-site trials.
- Demonstrated experience in oncology trial operations is strongly preferred
- In-depth understanding of the clinical development process and end-to-end trial delivery, with demonstrated expertise in feasibility, startup strategy, enrollment execution, quality oversight, and closeout.
- Strong and applied knowledge of GCP, regulatory requirements, inspection readiness, and compliance management, with experience supporting audits and regulatory inspections.
- Demonstrated leadership experience, including coaching, mentoring, and guiding other Local Operations Managers or site-facing roles in a player-coach…
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