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Job Function: R&D Operations Job Sub Function: Clinical Trial Support Job Category: Professional All Job Posting Locations: Connecticut (Any City), Delaware (Any City), Maine (Any City), Massachusetts (Any City), Michigan (Any City), New Hampshire (Any City), New Jersey (Any City), New York (Any City), Ohio (Any City), Pennsylvania (Any City), Raritan, New Jersey, United States of America, Rhode Island (Any City), Vermont (Any City) 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 We are searching for the best talent for a Senior Site Manager – Oncology.

This position can be located remotely in the Northeastern Region (ME, NH, VT, RI, CT, MA, NY, NJ, DE, PA, OH, or MI) of the United States. This is a remote role available in all cities within ME, NH, VT, RI, CT, MA, NY, NJ, DE, PA, OH, or MI.

Purpose: The Senior Site Manager (Senior SM) will serve as the primary contact point between the Sponsor and the Investigational Site. The Senior SM 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. This individual may assist with site selection, site qualification assessment, subject recruitment and retention planning, site initiation, on-site and remote monitoring and close-out activities.

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. May contribute to process improvement, training and the mentoring of other SMs. Operate independently with little or limited supervision.

You will be responsible for: Act as primary local company contact for assigned sites for specific trials. Actively participate in site feasibility and/or Site Qualification Visits (SQVs). Attend/participate in investigator meetings as needed.

May be expected to help prepare meeting materials and may be required to present at the investigator meeting. Execute 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. Implementation of analytical risk-based monitoring model at the site level and work with the site to ensure timely resolution of issues found during monitoring visits.

Implement and execute all tasks independently with little or limited supervision. Ensure site staff are trained, and the corresponding training records are complete and accurate at any point during all trial phases. Collaborate closely 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 shortest possible timeframe.

May be required to help provide solutions