Senior Local Operations Manager - Oncology - Hematology
Johnson & Johnson Innovative Medicine
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Benefits dieser Stelle
Zusammenfassung
Johnson & Johnson Innovative Medicine is seeking a Senior Local Operations Manager – Oncology to lead US country-level trial delivery from feasibility through closeout. You will collaborate with local teams, ensure compliance with SOPs and regulations, and influence global planning with site insights.
The role requires oncology trial operations experience, strong analytics, and excellent English communication.
Qualifikationen
- Bachelor-level life sciences or related field required; advanced degrees advantageous.
- Minimum 2 years in clinical trial operations, trial management, site management, or clinical monitoring.
- Oncology trial operations experience strongly preferred.
- Deep understanding of clinical development, feasibility, startup, enrollment, quality, and closeout.
- Strong analytical skills and ability to interpret country/site KPIs and mitigate risks.
- Excellent written and verbal communication in English; able to represent country in global forums.
- Willingness to travel up to 10% (overnight stays) as needed.
- Flexibility and resilience in a fast-changing clinical development environment.
Aufgaben
- Accountable for US site-level operational delivery from feasibility to closeout.
- Coordinate local trial team activities in compliance with SOPs and regulations.
- Plan local trials: procedures, recruitment, contingency and budget forecasting; mentor others as needed.
- Contribute to US trial strategy and align site insights with global planning.
- May serve as primary US operational interface to global trial leadership.
- Monitor country KPIs and identify systemic risks with mitigation strategies.
- Resolve site contracting, operational, and recruitment issues with cross-functional teams.
- Represent US operations in investigator meetings and governance forums.
- Develop protocol-specific expertise; potentially represent Oncology Site Enablement on cross-functional teams.
- Elevate US insights to inform global decision-making.
Kenntnisse
Ausbildung
Jobbeschreibung
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com
R&D Operations
Clinical Trial Project Management
Professional
Spring House, Pennsylvania, United States of America
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Our Oncology team is focused on the elimination of cancer by discovering new pathways and modalities to finding treatments and cures. We lead where medicine is going and need innovators with an unwavering commitment to results.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
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.
- 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.
- 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.
This job posting is anticipated to close on October 19th, 2026. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
Business Behavior, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trial Management Systems (CTMS), Clinical Trials, Communication, Give Feedback, Laboratory Operations, Medical Knowledge, Mentorship, Problem Solving, Process Oriented, Professional Ethics, Project Integration Management, Project Management, Research and Development, Research Ethics
$92,000.00 - $148,350.00
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is 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
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
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