Senior Site Manager - Cross Therapeutic Area - Florida

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.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

R&D Operations

Job Sub Function:

Clinical Trial Support

Job Category:

Professional

All Job Posting Locations:

Florida (Any City), Raritan, New Jersey, United States of America

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

Johnson & Johnson Innovative Medicine R&D is recruiting for a Senior Site Manager - Cross Therapeutic Area - Florida.

This is a remote role available within the state of Florida.  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.

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.

Principal Responsibilities:

• 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 to challenges faced in other sites in the country.

• Contribute to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas.

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

• Ensure that clinical drug supplies are appropriately used,