Remotery

Senior Local Operations Manager – Solid Tumor Oncology

atJohnson & JohnsonRemoteUS flagPennsylvaniaFull-timeOperationsSenior$92k – $148.4k/year

Posted 1 day ago

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

📋 Description

• Responsible for managing site-level operational execution for designated sites and trials from feasibility to closeout.

• Assist and coordinate activities of local trial teams in adherence to SOPs, procedures, and relevant regulations.

• Create trial-specific local procedures and tools.

• Strategize recruitment, contingency planning, risk management, and budget forecasting to achieve recruitment goals while delivering high-quality data punctually and within budget.

• Provide functional guidance and mentoring to other Local Operations Managers when necessary.

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

• Act as the primary operational liaison for US sites to global trial leadership when designated.

• Track country-level operational KPIs, pinpoint systemic risks, and develop mitigation strategies.

• Assist in escalating and resolving intricate site contracting, operational, and recruitment challenges.

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

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

• Represent Oncology Site Enablement on cross-functional teams.

• Amplify US site insights to support global decision-making and ongoing improvements.

• Lead or represent the functional area in Champion, Subject Matter Expert, and country, Delivery Unit, or global process initiatives.


⛳️ Requirements

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

• Generally, at least 2 years of experience in clinical trial operations, trial management, site management, or clinical monitoring 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.

• Familiarity with shaping or contributing to operational strategies at the country or trial level.

• Experience in site selection, enrollment forecasting, and risk mitigation planning.

• Excellent analytical skills to interpret country- and site-level KPIs, identify systemic risks, and execute corrective actions.

• Exceptional 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.

• Flexibility, resilience, and the ability to operate effectively in a 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.

• 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.

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