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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 https://www.jnj.com

Job Function:

R&D Operations

Job Sub Function:

Clinical Trial Support

Job Category:

Professional

All Job Posting Locations:

Abilene, Texas, United States, Abilene, Texas, United States, Akron, Ohio, United States, Allentown, Pennsylvania, United States, Alpharetta, Georgia, United States, Anaheim, California, United States, Anchorage, Alaska, United States, Annapolis, Maryland, United States, Appleton, Wisconsin, United States, Asheville, North Carolina, United States, Ashland, Kentucky, United States, Bangor, Maine, United States, Barnstable, Massachusetts, United States, Beckley, West Virginia, United States, Bellingham, Washington, United States, Billings, Montana, United States, Birmingham, Alabama, United States, Bismarck, North Dakota, United States, Bridgeport, Connecticut, United States, Burlington, Vermont, United States, Chandler, Arizona, United States, Charleston, South Carolina, United States, Chattanooga, Tennessee, United States, Colorado Springs, Colorado, United States of America, Columbia, Missouri, United States {+ 24 more}

Job Description:

About 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.

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

About Oncology

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

This is a remote role available in all states within the United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.

Remote work options may be considered on a case-by-case basis and if approved by the Company.

We are searching for the best talent for Senior Site Manager, Oncology, to be located remotely within the United States.

Purpose:

A Senior, Site Manager is a mid-level site management role with typically 3-5 years of

experience. This role serves as the primary contact point between the Sponsor and the

Investigational Site. A Senior, Site Manager is assigned to trial sites to ensure inspection

readiness through compliance with the clinical trial protocol, company Standard Operating

Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines

from study start-up through to site closure. Responsibilities may include assisting with site

selection, site qualification assessment, subject recruitment and retention planning, site

initiation, on-site and remote monitoring and close-out activities. The Senior, Site Manager will

partner with the Local Trial Manager (LTM), Clinical Trial Assistant (CTA) and TDL (Trial

Delivery Leader) to ensure overall site management while performing trial related activities for

assigned protocols. A Senior, Site Manager may contribute to process improvement, training

and mentoring of other Site Managers. A Senior, Site Manager is generally expected to be able

to operate independently with little or limited supervision.

You will be responsible for:

• Acts as primary local company contact for assigned sites for specific trials.

• May participate in site feasibility and/or pre-trial site assessment visits

• Attends/participates in investigator meetings as needed.

• Responsible for driving activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies. Responsible for the implementation of analytical risk based monitoring model at the site level and to work with site to ensure timely resolution of issues found during monitoring visits.

• Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases. Responsible in close collaboration with LTM and central study team for the activities during site activation phase in order to speed up the process and activate the site in the shortest possible timeframe.

• Involved with site level recruitment strategy and prioritization and implementation in partnership with other functional areas.

• Ensures site study supplies (such as Non-Investigational Product (IP), lab kits, etc.) are adequate for trial conduct.

• Ensures that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and detailed.

• Arranges for the appropriate destruction of clinical supplies.

• Ensures site staff complete data entry and resolve queries within expected timelines.

• Ensures accuracy, validity and completeness of data collected at trial sites

• Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs)/Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents.

• Maintains complete, accurate and timely data and essential documents in relevant systems used for trial management.

• Fully documents trial related activities, in particular monitoring. Writes visit reports and follow-up letter in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate stakeholders.

• Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times.

• Collaborates with LTM for documenting and communicating site/study progress and issues to trial central team.

• Aligns with relevant training requirements. Act as local expert in assigned protocols. Develops therapeutic knowledge sufficient to support role and responsibilities.

• Works closely with LTM to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified at the site during routine monitoring and other visit types, e.g. On Site Quality Monitoring Visit (OSQMV).

• Prepares trial sites for close out, conduct final close out visit.

• Tracks costs at site level and ensure payments are made, if applicable.

• Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff.

• May participate in the Health Authority (HA) and IEC/IRB submission and notification processes as required/appropriate.

• Acts as a point of contact in site management practices.

• May be assigned as a coach and mentor to a less experienced site manager.

• May contribute to process improvement and training.

• Leads and/or participates in special initiatives as assigned.

• May assume additional responsibilities or special initiatives such as "Champion" or "Subject Matter Expert".

This is not a comprehensive listing of job functions. May perform other duties as assigned.

Qualifications / Requirements:

• A minimum of a BA or BS degree is required.

• A minimum of 2 years of clinical trial monitoring experience is preferred, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.

• A minimum of 2 years of Oncology therapeutic area experience.

• Strong working knowledge of GCP, company SOPs, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.

• Strong IT skills in appropriate software and company systems.

• Willingness to travel up to 60% with overnight stay away from home.

• Proficient in speaking and writing English.

• Good written and oral communication.

The anticipated base pay range for this position in the US is $89,000 to $143,750. The anticipated base pay range for this position in San Francisco Bay Area is $103,000 to $165,600.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). Employees are eligible for the following time off benefits:

• Vacation – up to 120 hours per calendar year

• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year

• Holiday pay, including Floating Holidays – up to 13 days per calendar year

• Work, Personal and Family Time - up to 40 hours per calendar year

For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits

This job posting is anticipated to close on 9 April 2025.

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 and 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, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.