Senior Local Operations Manager - Solid Tumor Oncology
About The Position
The Senior Local Operations Manager (LOM) is an advanced operational leader accountable for US country-level site performance and operational delivery across the end-to-end clinical trial lifecycle. The role supports country operational strategy and execution, ensuring high-quality delivery aligned with global trial objectives. It may include leading and mentoring Local Operations Managers, resolving complex escalations, and integrating country-level operational insights into global trial planning and execution. Operating as a player coach, the Senior LOM may mentor other Local Operations Managers while directly managing strategic or high-impact sites and programs. The position aligns site-level execution with global trial objectives and supports delivery against operational KPIs related to feasibility, startup, enrollment, data quality, compliance, and closeout. The role is remote in the United States and may require travel up to 10%, including overnight stays.
Requirements
- Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or a related scientific discipline, or equivalent experience.
- Typically, at least 2 years of experience in clinical trial operations, trial management, site management, or clinical monitoring, including significant experience with complex, high-priority, or multisite trials.
- In-depth understanding of the clinical development process and end-to-end trial delivery, including feasibility, startup strategy, enrollment execution, quality oversight, and closeout.
- Strong applied knowledge of GCP, regulatory requirements, inspection readiness, and compliance management, with experience supporting audits and regulatory inspections.
- Experience shaping or contributing to country-level or trial-level operational strategy, including site selection, enrollment forecasting, and risk mitigation planning.
- Strong analytical skills, including the ability to interpret country- and site-level KPIs, identify systemic risks, and implement corrective actions.
- Excellent written and verbal communication skills in the local country language and English, with the ability to represent the country or region in global forums.
- Willingness to travel up to 10% as required, including overnight stays and participation in investigator meetings and key trial governance meetings.
- Flexibility, resilience, and ability to operate effectively in a complex, fast-changing clinical development environment.
Nice To Haves
- Advanced scientific or clinical degree.
- Demonstrated experience in oncology trial operations.
Responsibilities
- Account for US site-level operational delivery for assigned sites and trials from feasibility through closeout.
- As appropriate, support and coordinate local trial team activities in compliance with SOPs, procedural documents, and applicable regulations.
- Plan local trial operations to meet recruitment targets and deliver high-quality data on time and within study budget, including developing trial-specific procedures and tools, recruitment plans, contingency and risk management, and budget forecasts.
- As appropriate, provide functional guidance and mentoring to other Local Operations Managers assigned to a trial or program.
- Contribute to US trial operational strategy and integrate site insights into global feasibility and startup planning.
- Serve, as needed, as the primary US operational interface to global trial leadership.
- Monitor country-level operational KPIs and identify systemic risks and mitigation strategies.
- Support escalation and resolution of complex site contracting, operational, and recruitment issues in collaboration with leads and cross-functional partners.
- Represent US local operations at investigator or study coordinator site meetings and key governance forums.
- Act as a subject matter expert for assigned protocols and develop therapeutic knowledge to support role responsibilities; may represent Oncology Site Enablement on cross-functional teams.
- Elevate US site insights to inform global decision-making and continuous improvement.
- Take on additional responsibilities or special initiatives, such as Champion or Subject Matter Expert roles, and represent the functional area or lead country, Delivery Unit, and global-level process initiatives as required.
Benefits
- Participation in the Company’s consolidated retirement plan (pension) and savings plan (401(k)), subject to plan terms.
- Eligibility to participate in the Company’s long-term incentive program.
- Vacation: 120 hours per calendar year.
- Sick time: 40 hours per calendar year; 48 hours for employees residing in Colorado and 56 hours for employees residing in Washington.
- Holiday pay, including floating holidays: 13 days per calendar year.
- Work, Personal and Family Time: up to 40 hours per calendar year.
- Parental Leave: 480 hours within one year of the birth, adoption, or foster care of a child.
- Bereavement Leave: 240 hours for an immediate family member and 40 hours for an extended family member per calendar year.
- Caregiver Leave: 80 hours in a 52-week rolling period.
- Volunteer Leave: 32 hours per calendar year.
- Military Spouse Time-Off: 80 hours per calendar year.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
