Senior Site Manager - Oncology - Northeast U.S.

Job description

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: 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 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, handled and stored and returns are accurately inventoried and documented. Arrange for the appropriate destruction of clinical supplies. Ensure site staff complete data entry and resolve queries within expected timelines. Ensure accuracy, validity and completeness of data collected at trial sites. Proactively ensure 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, ensure that they are consistent with all data collected and with the information in the source documents. Maintain complete, accurate and timely data and essential documents in relevant systems utilized for trial management. Fully document trial related activities, in particular monitoring. Write visit reports and follow-up letters in accordance with the SOPs. Promptly communicate relevant status information and issues to appropriate stakeholders. Reviews study files for completeness and ensure archiving retention requirements are met, including storage in a secure area at all times. Collaborate with LTM for documenting and communicating site/study progress and issues to trial central team. Attend regularly scheduled team meetings and trainings. Comply with relevant training requirements. Act as local expert in assigned protocols. Possess proficient therapeutic knowledge sufficient to support role and responsibilities. Work 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., Compliance Monitoring Visit (CMV)). May be required to oversee audit and inspection preparation by Associate SM. Prepare trial sites for close out and conduct final close out visit. Track costs at site level and ensure payments are made, if applicable. Establish and maintain 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 Independent Ethics Committee (IEC)/Institutional Review Board (IRB) submission and notification processes as required/appropriate. Act as a point of contact in site management practices. Provide credible and useful insights and input. May be assigned as a coach and mentor to a less experienced site manager. May be required to contribute to process improvement and training. Occasionally lead and/or participate in special initiatives as assigned. May assume additional responsibilities or special initiatives such as “Champion” or Subject Matter Expert”. Quali