Lead Local Operations Manager – Solid Tumor Oncology

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

📋 Description

• Take responsibility for operational delivery at the US site level for designated locations.

• Direct and synchronize local trial team efforts in accordance with standard operating procedures (SOPs), procedural documentation, and relevant regulations.

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

• Formulate trial-specific procedures and tools tailored to local needs.

• Develop recruitment strategies and oversee contingencies, risk management, and budget forecasting.

• Provide leadership and mentoring to Local Operations Managers assigned to the trial or program.

• Influence the US trial operational strategy and incorporate site insights into global feasibility and startup planning.

• Act as the main US operational contact for global trial leadership.

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

• Serve as the escalation point for intricate site contracting, operational issues, and recruitment challenges.

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

• Act as a subject matter expert for assigned protocols and enhance therapeutic knowledge.

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

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

• Undertake additional responsibilities or special initiatives, such as Champion or Subject Matter Expert roles.

• Represent the functional area or lead country, Delivery Unit, and global-level process initiatives.

• Willing to travel approximately 10% of the time.

⛳️ Requirements

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

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

• Considerable experience with complex, high-priority, or multi-site trials is essential.

• 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 Good Clinical Practice (GCP), regulatory standards, inspection readiness, and compliance management.

• Experience in supporting audits and regulatory inspections is necessary.

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

• Ability to lead by influence, address escalations, and align cross-functional and global trial teams.

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

• Strong analytical skills for interpreting country- and site-level KPIs, identifying systemic risks, and implementing corrective actions.

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

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

• Demonstrated flexibility, resilience, and ability to function effectively in a dynamic, complex 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; Colorado employees receive 48 hours; Washington employees receive 56 hours per calendar year.

• 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.

• Remote work arrangement available.

• Equal opportunity and inclusive interview process.

• Disability accommodation support offered.