Senior Local Operations Manager – Solid Tumor Oncology

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

📋 Description

• Take charge of US site-level operational delivery for designated sites and trials from feasibility through to closeout.

• Assist and coordinate local trial team activities while adhering to SOPs, procedural documents, and relevant regulations.

• Strategize local trial activities to achieve recruitment goals and provide high-quality data promptly and within budget.

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

• Spearhead recruitment planning, manage contingencies and risks, and forecast budgets.

• Offer functional guidance and mentorship to Local Operations Managers as necessary.

• Contribute to the operational strategy for US trials and integrate site insights into global feasibility and startup planning.

• Act as the main US operational liaison to global trial leadership when designated.

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

• Assist in the escalation and resolution of intricate site contracting, operational, and recruitment challenges.

• Collaborate with Leads and cross-functional teams.

• Represent US local operations at site meetings with investigators and study coordinators, as well as governance forums.

• Serve as a subject matter expert for assigned protocols and cultivate therapeutic knowledge.

• Represent Oncology Site Enablement on cross-functional teams when appointed.

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

• Lead or represent country, Delivery Unit, and global process initiatives, along with special initiatives such as Champion or Subject Matter Expert.

⛳️ Requirements

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

• At least 2 years of experience in clinical trial operations, trial management, site management, or clinical monitoring, including substantial experience with complex, high-priority, or multi-site trials.

• Proven experience in oncology trial operations is highly preferred.

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

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

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

• Experience in supporting audits and regulatory inspections.

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

• Strong analytical abilities to interpret country- and site-level KPIs, identify systemic risks, and implement corrective measures.

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

• Willingness to travel up to 10%, which may include overnight stays and participation in investigator meetings and essential trial governance meetings.

• Demonstrated adaptability, resilience, and capability to function effectively in a highly complex, rapidly changing clinical development environment.

🏝️ 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 per calendar year for employees residing in Colorado; 56 hours per calendar year 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/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.

• 10 days Volunteer Leave – 32 hours per calendar year.

• Military Spouse Time-Off – 80 hours per calendar year.

• Inclusive interview process and accommodation support.