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Lead, trial delivery manager - oncology

Johnson & Johnson Innovative Medicine
Delivery manager
Pubblicato il 23 gennaio
Descrizione

PpAt 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. /p h3Lead, Trial Delivery Manager, Oncology /h3 h3Job Function /h3 pRD Operations /p h3Job Sub Function /h3 pClinical Trial Project Management /p h3Job Category /h3 pProfessional /p h3Locations /h3 ul liBeerse, Belgium /li liLeiden, Netherlands /li liMadrid, Spain /li liWarsaw, Poland /li liLisbon, Portugal /li liMilan, Italy /li /ul h3Requisition Numbers by Country /h3 ul liUnited States – R- /li liUnited Kingdom – R- /li liBelgium, Netherlands, Poland, Spain, Portugal, Italy – R- /li /ul h3About Innovative Medicine /h3 pOur 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 /p h3About Oncology /h3 pOur 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. /p h3Important Note /h3 pThis 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. /p h3Purpose /h3 pThe 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. /p h3Primary Responsibilities /h3 ul liCreate and update critical trial‑specific documents (e.g., Monitoring Guidelines, Informed Consent Form, Investigational Medicinal Product (IMP) related documentation). /li liManage vendor set‑up and day‑to‑day study vendor activities, including set‑up, SOW creation and budget oversight. /li liCoordinate 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). /li liSupport development of program‑level compound training, collaborating with Clinical / CTLT / Medical writing. /li liProvide input into trial‑level operational strategies. /li liResolve trial‑related issues and mitigate trial‑related risks. /li liParticipate in process improvement activities at a trial, compound cross‑DU level, as needed. /li liProvide support during Health Authority inspections and identify risks and mitigation plans at the program level for key issues. /li liMentor and support onboarding of new team members, particularly those in Trial Management. /li /ul h3Principal Relationships /h3 pInternal: Trial Management Directors, Clinical Trial Leaders, Clinical Trial Assistants, Representatives of Delivery Operations, representatives of other GD Functions and Clinical Teams, representatives of Procurement.br/External: Vendors. /p h3Qualifications / Requirements /h3 ul liBS degree or equivalent; preferred study areas include Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy). /li liMinimum of 4 years clinical trial experience in Pharmaceutical, Healthcare or related industries. /li liClinical research operational knowledge and experience across multiple phases of studies (Phase I‑IV); ability to manage multiple aspects of execution of a clinical trial. /li li2‑3 years’ experience supporting multiple aspects of a global clinical trial. /li liMinimum of 2 years of oncology clinical trial experience. /li liCAR‑T experience would be a plus. /li liExcellent leadership skills and proven ability to foster team productivity and cohesiveness. /li liExperience leading without authority and in multi‑functional matrixed and global environments. /li liExcellent decision‑making, analytical and strong financial management skills are essential to this position. /li liOperate and execute with limited supervision. /li liExperience mentoring/coaching others. /li liStrong project planning/management, communication and presentation skills are required. /li liAbility to think strategically and work through ambiguous situations. /li liAbility and experience to lead the Study Management Meetings. /li liExperience and skills utilizing technology (e.g. tools, systems with GenAI enabled capabilities) to obtain reports for efficient metric oversight. /li liTravel up to 15‑20% of the time, defined by business needs. /li /ul h3Required Skills /h3 pAnalytical 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). /p h3Preferred Skills /h3 pAnalytical 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). /p /p #J-18808-Ljbffr

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