Manager, Trial Delivery Management

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 Project Management Job Category: Professional All Job Posting Locations: Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America Job Description: 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   We are searching for the best talent for Manager, Trial Delivery Management (TDM) to be located in one of the following locations (Hybrid). (Remote working will be considered on a case by case basis and with approval of the business). High Wycombe / Maidenhead, United Kingdom Beerse, Belgium Breda, Netherlands Madrid, Spain Spring House/ Titusville / Raritan / Horsham, United States Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): United Kingdom- Requisition Number: R-086693 Belgium, Spain, Netherlands- Requisition Number: R-094113 United States- Requisition Number: R-094118 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Summary: The Manager, Trial Delivery Management (TDM) is responsible for the execution of study-level activities, creating and updating trial-specific documents, vendor oversight & delivery, compound training, and other activities. The Manager TDM is responsible for country and regional oversight of local operational delivery, including the alignment of the feasibility strategy and target setting, risk reviews and local challenges that could impact overall study delivery. You will be responsible for: Creating and updating critical trial-specific documents (e.g., Monitoring Guidelines, Informed Consent Form, Investigational Medicinal Product [IMP] related documentation). Vendor set up and management of day-to-day study vendor activities, including set-up, SOW creation and budget oversight. Responsible for country / regional coordination of trial management activities and oversight (e.g., aligns feasibility strategy with local teams, perform country-level risk reviews, aware of all projects conducted across countries). Supporting development of program-level compound training, collaborating with Clinical / CTL&D / Medical writing. Providing input into trial level operational strategies. Resolve trial-related issues and mitigate trial-related risks. Participating in process improvement activities at a trial, compound & cross-DU level, as needed. Providing support during Health Authority