Lead, Local Operations Manager – Solid Tumor Oncology

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

📋 Description

• Manage operational delivery at US site level for designated locations.

• Direct and coordinate activities of the local trial team in adherence to SOPs, procedures, and regulatory standards.

• Oversee local project planning for recruitment goals, quality data, timelines, and study budgets.

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

• Provide leadership oversight and mentorship to Local Operations Managers.

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

• Act as the primary operational contact for US matters in relation to global trial leadership.

• Track country-level operational KPIs and pinpoint systemic risks along with mitigation strategies.

• Address complex issues related to site contracting, operations, and recruitment.

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

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

• Act as a representative of Oncology Site Enablement on cross-functional teams when necessary.

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

• Assume Champion or Subject Matter Expert roles and spearhead country, Delivery Unit, or global process initiatives.

• Travel approximately 10% of the time.

⛳️ Requirements

• A minimum of a bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related scientific field, or equivalent experience.

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

• Significant experience with complex, high-priority, or multi-site trials.

• Experience in oncology trial operations is strongly preferred.

• Comprehensive understanding of clinical development and complete trial delivery processes.

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

• Strong knowledge of GCP, regulatory standards, 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.

• Ability to lead through influence, address escalations, and promote cross-functional and global alignment.

• Experience with country-level or trial-level operational strategy, site selection, enrollment forecasting, and risk mitigation planning.

• Strong analytical capabilities and the ability to interpret country- and site-level KPIs and implement corrective measures.

• 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 and governance meetings.

• Flexibility, resilience, and the ability to thrive in a complex, rapidly evolving clinical development landscape.

🏝️ Benefits

• Consolidated retirement plan (pension).

• Savings plan (401(k)).

• Long-term incentive program.

• Vacation – 120 hours per calendar year.

• Sick time – 40 hours per calendar year; 48 hours for Colorado employees; 56 hours for Washington employees.

• 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.