Lead Local Operations Manager – Solid Tumor Oncology

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• Oversee operational delivery for designated US sites.

• Direct and coordinate activities of local trial teams in accordance with SOPs, procedural documents, and relevant regulations.

• Lead local project planning to achieve recruitment goals and ensure timely delivery of high-quality data within the study budget.

• Create local trial-specific procedures and tools, recruitment strategies, contingency plans, risk management plans, and budget forecasts.

• Provide leadership oversight and mentoring to other Local Operations Managers.

• Shape the operational strategy for US trials and incorporate site insights into global feasibility and startup planning.

• Act as the primary US operational liaison to global trial leadership.

• Monitor operational KPIs at the country level and recognize systemic risks along with mitigation strategies.

• Serve as the escalation point for intricate issues related to site contracting, operations, and recruitment.

• Represent US local operations during investigator or study coordinator meetings and governance forums.

• Act as a subject matter expert for assigned protocols while developing therapeutic knowledge.

• Represent Oncology Site Enablement in cross-functional teams.

• Elevate US site insights to guide global decision-making and foster continuous improvement.

• Take on additional Champion or Subject Matter Expert initiatives and lead country, Delivery Unit, or global process initiatives.

• Travel approximately 10% of the time.

⛳️ Requirements

• A bachelor’s degree in Life Sciences, Nursing, Pharmacy, or a related scientific field (or equivalent experience) is essential.

• At least 4 years of experience in clinical trial operations, trial management, site management, or clinical monitoring.

• Experience in managing complex, high-priority, or multi-site trials is required.

• Proven experience in oncology trial operations is highly preferred.

• Comprehensive understanding of the clinical development process and complete trial delivery.

• Proficiency in feasibility, startup strategy, enrollment execution, quality oversight, and trial closeout.

• Strong knowledge of GCP, regulatory requirements, inspection readiness, and compliance management.

• Experience in supporting audits and regulatory inspections.

• Leadership experience in coaching, mentoring, and guiding Local Operations Managers or site-facing roles.

• Capability to lead through influence, resolve escalations, and drive alignment among cross-functional and global trial teams.

• Experience in shaping or contributing to operational strategy at the country or trial level, including site selection, enrollment forecasting, and risk mitigation planning.

• Strong analytical skills to interpret country- and site-level KPIs and implement corrective actions.

• Excellent written and verbal communication skills in both the local language and English.

• Willingness to travel up to 10%, including overnight stays and participation in investigator meetings and key trial governance meetings.

• Ability to function effectively in a highly complex and rapidly evolving clinical development environment.

🏝️ Benefits

• Consolidated retirement plan (pension).

• Savings plan (401(k)).

• Vacation – 120 hours per calendar year.

• Sick time – 40 hours per calendar year; 48 hours for employees in Colorado; 56 hours for employees 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/foster care of a child.

• Bereavement Leave – 240 hours for an immediate family member; 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.

• Inclusive interview process and disability accommodations.