Note: The job is a remote job and is open to candidates in USA. Johnson & Johnson Innovative Medicine is hiring a Senior Local Operations Manager to lead US site-level operational delivery across the clinical trial lifecycle for solid tumor oncology. The role supports country-level trial strategy, manages operational risks and escalations, and aligns site execution with global trial objectives.
Responsibilities
- Accountable for US site level operational delivery for assigned sites and trials from feasibility through closeout
- As appropriate, supports and coordinates local trial team activities in compliance with SOPs, other procedural documents, and applicable regulations
- Responsible for local project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget, including but not limited to: development of local trials specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting. As appropriate, may provide functional guidance and mentoring support to other local operations managers assigned to the trial or program
- Contributes to US trial operational strategy and integrates site insights into global feasibility and startup planning
- May serve as the primary US operational interface to global trial leadership
- Monitors country level operational KPIs and identifies systemic risks and mitigation strategies
- Supports escalation and resolution of complex site contracting, operational, and recruitment issues, collaborating with Leads and cross-functional partners, as needed
- Represents US local operations at investigator and/or study coordinator site meetings and key governance forums
- Acts as subject matter expert for assigned protocols and develops strong therapeutic knowledge to support roles and responsibilities. May represent Oncology Site Enablement on cross functional teams
- Elevates US site insights to inform global decision-making and continuous improvement
- Expected to assume additional responsibilities or special initiatives such as “Champion” or “Subject Matter Expert” and to represent the functional area or lead country, Delivery Unit, and global level process initiatives, as required
Skills
- A minimum of a bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related scientific discipline (or equivalent experience) is required
- Typically, a minimum of 2 years of experience in clinical trial operations, trial management, site management, or clinical monitoring, including significant experience in complex, high-priority, or multi-site trials
- In-depth understanding of the clinical development process and end-to-end trial delivery, with demonstrated expertise in feasibility, startup strategy, enrollment execution, quality oversight, and closeout
- Strong and applied knowledge of GCP, regulatory requirements, inspection readiness, and compliance management, with experience supporting audits and regulatory inspections
- Experience shaping or contributing to country-level or trial-level operational strategy, including site selection, enrollment forecasting, and risk mitigation planning
- Strong analytical skills with the ability to interpret country- and site-level KPIs, identify systemic risks, and implement corrective actions
- Excellent written and verbal communication skills in both the local country language and English, with demonstrated ability to represent the country or region in global forums
- Demonstrated flexibility, resilience, and ability to operate effectively in a highly complex, fast-changing clinical development environment
- Advanced scientific or clinical degrees are an advantage
- Demonstrated experience in oncology trial operations is strongly preferred
Benefits
- Employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)), subject to the terms of their respective plans.
- Eligible to participate in the Company’s long-term incentive program.
- Vacation – 120 hours per calendar year.
- Sick time – 40 hours per calendar year; for employees who reside in the State of Colorado – 48 hours per calendar year; for employees who reside in the State of Washington – 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 period10 days.
- Volunteer Leave – 32 hours per calendar year.
- Military Spouse Time-Off – 80 hours per calendar year.
- Remote work in the United States.
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