Lead, Trial Delivery Manager

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.Lead, Trial Delivery Manager, OncologyJob FunctionR&D OperationsJob Sub FunctionClinical Trial Project ManagementJob CategoryProfessionalLocationsBeerse, BelgiumLeiden, NetherlandsMadrid, SpainWarsaw, PolandLisbon, PortugalMilan, ItalyRequisition Numbers by CountryUnited States – R-******United Kingdom – R-******Belgium, Netherlands, Poland, Spain, Portugal, Italy – R-******About Innovative MedicineOur 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 OncologyOur Oncology team is focused on the elimination of cancer by discovering new pathways and modalities to find 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.Important NoteThis 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).Your applications will be considered as a single submission.Remote work options may be considered on a case-by-case basis and if approved by the Company.PurposeThe 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 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.Primary ResponsibilitiesCreate and update critical trial-specific documents (e.g., Monitoring Guidelines, Informed Consent Form, Investigational Medicinal Product [IMP] related documentation).Manage vendor set-up and day-to-day study vendor activities, including set-up, SOW creation and budget oversight.Coordinate country/regional trial management activities and oversight (e.g., align feasibility strategy with local teams, perform country-level risk reviews, be aware of all projects conducted across countries).Support development of program-level compound training, collaborating with Clinical / CTL&T / Medical writing.Provide input into trial-level operational strategies.Resolve trial-related issues and mitigate trial-related risks.Participate in process improvement activities at a trial, compound & cross-DU level, as needed.Provide support during Health Authority inspections and identify risks and mitigation plans at the program level for key issues.Mentor and support onboarding of new team members, particularly those in Trial Management.Principal RelationshipsInternal: 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: Vendors.Qualifications / RequirementsBS degree or equivalent; preferred study areas include Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).Minimum of 4 years clinical trial experience in Pharmaceutical, Healthcare or related industries.Clinical research operational knowledge and experience across multiple phases of studies (Phase I-IV); ability to manage multiple aspects of execution of a clinical trial.2-3 years' experience supporting multiple aspects of a global clinical trial.Minimum of 2 years of oncology clinical trial experience.CAR-T experience would be a plus.Excellent leadership skills and proven ability to foster team productivity and cohesiveness.Experience leading without authority and in multi-functional matrixed and global environments.Excellent decision-making, analytical and strong financial management skills are essential to this position.Operate and execute with limited supervision.Experience mentoring/coaching others.Strong project planning/management, communication and presentation skills are required.Ability to think strategically and work through ambiguous situations.Ability and experience to lead the Study Management Meetings.Experience and skills utilizing technology (e.g. tools, systems with GenAI enabled capabilities) to obtain reports for efficient metric oversight.Travel up to *****% of the time, defined by business needs.Required SkillsAnalytical Reasoning, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trial Management Systems (CTMS), Clinical Trials, Communication, Data Savvy, Laboratory Operations, Organizing, Problem Solving, Productivity Planning, Professional Ethics, Project Integration Management, Quality Assurance (QA), Regulatory Compliance, Research and Development, Research Ethics, Standard Operating Procedure (SOP).Preferred SkillsAnalytical Reasoning, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trial Management Systems (CTMS), Clinical Trials, Communication, Data Savvy, Laboratory Operations, Organizing, Problem Solving, Productivity Planning, Professional Ethics, Project Integration Management, Quality Assurance (QA), Regulatory Compliance, Research and Development, Research Ethics, Standard Operating Procedure (SOP).#J-*****-Ljbffr