Ph3Overview /h3pAt 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 /ph3Job Function /h3pRD Operations /ph3Job Sub Function /h3pClinical Trial Project Management /ph3Job Category /h3pProfessional /ph3All Job Posting Locations /h3pBeerse, Antwerp, Belgium, Berlin, Germany, Issy-les-Moulineaux, France, Leiden, Netherlands, Lisbon, Portugal, Madrid, Spain, Milano, Italy, Stockholm, Stockholm, Sweden, Warsaw, Masovian, Poland /ph3Job Description /h3pstrongPosition Summary /strong: 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 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. /ph3Principal Responsibilities /h3ulliCreate and update critical trial-specific documents (e.g., Monitoring Guidelines, Informed Consent Form, Investigational Medicinal Product (IMP) related documentation). /liliVendor set up and management of day-to-day study vendor activities, including set-up, SOW creation and budget oversight. /liliResponsible 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). /liliSupport development of program-level compound training, collaborating with Clinical / CTLD Medical writing. /li /ulh3Additional Responsibilities May Include /h3ulliProvide input into trial level operational strategies. /liliResolve trial-related issues and mitigate trial-related risks. /liliParticipate in process improvement activities at a trial, compound cross-DU level, as needed. /liliProvide support during Health Authority inspections and on the identification of risks and mitigation plans at the program level for key issues. /liliMentor support onboarding of new team members, particularly those in Trial Management. /liliFoster employee engagement, inclusion, and Credo Behaviors. /li /ulh3Principal Relationships /h3pInternal: 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 /ph3Education And Experience Requirements /h3pstrongRequired Minimum Education: /strong BS degree or equivalent, preferred areas of study include Life Sciences (Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)). /ppstrongRequired Years Of Related Experience /strong Minimum of 8 years in Pharmaceutical, Healthcare or related industries. /ph3Required Knowledge, Skills And Abilities /h3ulliExperience in and knowledge of the pharmaceutical development process. /liliClinical research operational knowledge and experience across multiple phases of studies (Phase I-IV); must have the ability to manage all aspects of execution of a clinical trial. /lili2-3 years’ experience leading multiple aspects of a global clinical trial /liliMust possess excellent leadership skills and proven ability to foster team productivity and cohesiveness. /liliExperience of leading without authority and in multi-functional matrixed and global environments. /liliExcellent decision-making, analytical and strong financial management skills are essential to this position. /liliOperate and execute with limited supervision. /liliExperience mentoring/coaching others. /liliStrong project planning/management, communication and presentation skills are required. /li /ulh3Education And Skills /h3h3Preferred Skills /h3ulliAnalytical Reasoning /liliBudgeting /liliClinical Trial Management Systems (CTMS) /liliClinical Trials /liliCompliance Management /liliContract Management /liliExecution Focus /liliFact-Based Decision Making /liliLaboratory Operations /liliMentorship /liliProcess Improvements /liliProject Integration Management /liliResearch and Development /liliResearch Ethics /liliStandard Operating Procedure (SOP) /liliTechnical Credibility /li /ul /p #J-18808-Ljbffr