Associate Site Manager - Oncology - Southeast U.S

Position: Associate Site Manager - Oncology - Southeast U.S.
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 Med Tech, 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.

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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), Georgia (Any City), Maryland (Any City), North Carolina (Any City), Raritan, New Jersey, United States of America, South Carolina (Any City), Virginia (Any City), Washington, District of Columbia, United States of America, West Virginia (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

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

We are searching for the best talent for an Associate Senior Site Manager - Oncology. This position can be located remotely in the Southeastern Region (DC, VA, MD, NC, SC, GA, FL, or WV) of the United States.

This is a remote role available in all cities within VA, MD, NC, SC, GA, FL or WV.

Purpose:

The Associate Site Manager (Associate SM) will serve as the primary contact point between the Sponsor and the Investigational Site. The Associate 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 and training. Some supervision from a more Senior Site Manager (Senior SM or Lead SM) to help provide guidance.

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.
• 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.
  
  Occasionally may require assistance or oversight from Lead SM or LTM.
• 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.
• 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, handled and stored and returns are accurately inventoried and documented.
• Arrange for the appropriate destruction…