Senior Local Operations Manager - Solid Tumor Oncology (1 of 5 Openings)

Johnson & Johnson Innovative Medicine•Spring House, PA

1d•Remote

About The Position

The Senior Local Operations Manager (LOM) is an advanced operational leader accountable for US country level site performance and operational delivery across the end-to-end clinical trial lifecycle. The Senior LOM supports country operational strategy and execution, ensuring high-quality delivery aligned with global trial objectives. The Senior LOM may be assigned to lead Local Operations Managers, resolving complex escalations, and integrating country level operational insights into global trial planning and execution. Operating as a player coach, the Senior LOM may mentor other Local Operations Managers while directly managing strategic or high-impact sites and programs. The role drives strong alignment between site level execution and global trial objectives, ensuring delivery against key operational KPIs related to feasibility, startup, enrollment, data quality, compliance, and closeout.

Requirements

A minimum of a bachelor’s degree in Life Sciences, Nursing, Pharmacy, or a related scientific discipline (or equivalent experience) is required; advanced scientific or clinical degrees are an advantage.
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.
Demonstrated experience in oncology trial operations is strongly preferred
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.
Willingness to travel up to 10% as required, including overnight stays and participation in investigator meetings and key trial governance meetings.
Demonstrated flexibility, resilience, and ability to operate effectively in a highly complex, fast-changing clinical development environment.

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.

Benefits

medical, dental, vision, life insurance, short and long-term disability, business accident insurance, and group legal insurance.
consolidated retirement plan (pension) and savings plan (401(k)).
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 period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year