Lead, Trial Delivery Manager - 2 positions

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: Madrid, Spain, Milano, Italy, Warsaw, Masovian, Poland 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 a   Lead, Trial Delivery Manager (TDM)   to be located in one of the following locations (Hybrid or Remote working will be considered, depending on location and on a case-by-case basis). Madrid, Spain Milan, Italy Warsaw, Poland Position Summary: The   Lead Trial Delivery Manager (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 Lead 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). Managing 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. Resolving trial-related issues and mitigate trial-related risks. Participate in process improvement activities at a trial, compound & cross-DU level, as needed. Providing support during Health Authority inspections and on the identification of risks and mitigation plans at the program level for key issues. Mentoring & supporting onboarding of new team members, particularly those in Trial Management. Principal Relationships: Internal: Trial Management Directors, Clinical Trial Leaders, Clinical Trial Assistants, Representatives of Delivery Operations, representatives of other GD Functions and Clinical Teams, representatives of Procurement External: Travel up to 15-20% of the time, defined by business needs. Are you ready to join our team? Then please read further!

Requirements BS degree or equivalent, preferred areas of study include Life Sciences (Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy) Minimum of 4 years clinical trial experience in Pharmaceutical, Healthcare or related