H3Global Senior Trial Delivery Manager - Sponsor Dedicated /h3pJoin to apply for the strongGlobal Senior Trial Delivery Manager - Sponsor Dedicated /strong role at strongIQVIA /strong /ph3Global Senior Trial Delivery Manager - Sponsor Dedicated /h3p1 day ago Be among the first 25 applicants /ppJoin to apply for the strongGlobal Senior Trial Delivery Manager - Sponsor Dedicated /strong role at strongIQVIA /strong /ppGet AI-powered advice on this job and more exclusive features. /ppGlobal Trial Delivery Manager services provide for the global coordination of clinical trial management activities for internally managed and/or outsourced trials. These services lead the Study Management Team (SMT) and ensure global clinical operations deliverables progress according to agreed upon timelines and milestones, including country site feasibility and site selection, trial set-up, trial execution and trial closure and vendor set up activities as assigned by the Global Clinical Development Operations Trial Leader (GTL). This service supports the GTL in leading related CRO, country, and site activities, including global vendors involved in site facing activities such as IVRS, Central Lab, ePRO, Imaging, Translation, Printing, Ancillary supplies and Meeting Planners. Interface with stakeholders; internal and external to Global Clinical Development Operations (GCDO) functions, such as Study Responsible Physician, Global Data Manager, Trial Supply Manager, CRO staff, vendor staff and trial sites (if applicable). Work closely with the GCDO Trial Leader (GTL) and is member of the Trial Team, led by the GTL. Ensure inspection readiness through compliance with the clinical research protocol, company Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP), applicable regulations and guidelines from start-up through close-out. Takes ownership for assigned responsibilities. Demonstrated competency to act as a backup or first point of contact in absence of the GCDO Trial Leader. Advanced is given assignments that are more complex and/or have a greater potential impact on business results. May act as the lead over a team of CTMs across a project/program, on insourced and outsourced studies. Able to lead taskforces and provide innovative input. May contribute to process improvement and/or non-project work.brstrongTask:br/strongulliServices rendered will adhere to applicable to sponsor´s SOPs, WIs, policies, codes of Good Clinical Practice (GCP), local regulatory requirements, etc. /liliComplies with relevant training requirements. /liliLead the Study Management Team including providing updates to all trial team members on deliverable status. /liliEnsure availability of required reports to support real time tracking of trial status according to trial plan. /liliManage timely and accurate documentation and communication of trial progress. /liliEnsure that the Study Management Team (SMT) operates in a constant state of inspection-readiness. /liliAct as primary contact for Country and Regional staff. /liliAct as the primary contact person for the local teams within GCDO. /liliPartner with the Global Trial Lead to execute and oversee central activities from planning, trial start up, through the life of trial to close-out. /liliEnsure issue escalation and drive issue resolution. /liliWork closely with Trial Team to ensure CAPAs are resolved timely. Act as CAPA owner or contributor, as appropriate. /liliContribute to data collection to support the site selection process. /liliParticipate in feasibility, providing recommendations as needed. /liliEstablish enrollment commitments and ensure actual enrollment meets projected commitments across the regions at the clinical trial level. /liliEnsure the availability of robust recruitment/contingency plans are in place for each region. /liliEnsure timely tracking and filing in appropriate systems, as required at central trial oversight level. /liliPerform Annual Quality Review of files, as appropriate. /liliEnsure archiving and retention of documents per set requirements. /liliEstablish country budgets and monitor actuals vs. forecast for Out-of-Pocket Expenses. /liliOversight of selected vendors and status of related deliverables. /liliReview and approve assigned vendor invoices/spend. /liliMonitor budgets and expenditures as expected per planned trial budget. /liliCreate and update trial-specific documents as required, including Monitoring Guidelines, Informed Consent Form, Investigational Medicinal product (IMP) related documentation, Blinding Plan, country and site feasibility related documents. /liliProvide input into cross functional documents such as safety related documents, protocol deviations and issue escalation processes, External Service Provider Oversight Plan and the Filing and Archiving Plan. /liliProvide central documents required for HA/EC/IRB submission. /liliEnsures creation of appropriate trial-specific training materials and requirements, making them available to the regional/site/CRO staff and delivering training as needed. /liliResponsible for the set-up, coordination, attendance participation of Investigator Meetings. /liliEstablish and maintain excellent working relationships with internal stakeholders, such as country representatives, data management leader and clinical supplies unit. /liliDemonstrate deep knowledge of protocol and procedures and adequate therapeutic area knowledge. /liliEnsure compliance with Health Authority regulations and guidelines and internal standard operating procedures and processes. /liliParticipate in preparation for, and conduct of, Health Authority inspections and internal audits. /liliWork with Bioresearch Quality Compliance (BRQC) liaisons to ensure quality oversight of assigned trial utilizing the available tools. /liliCoordinate data cleaning with some supervision towards a timely and successful database lock. /liliAct as central expert for assigned protocol(s). /liliSufficient therapeutic knowledge to support defined CTM roles and responsibilities. /liliContribute to process improvement and training, as applicable.br/li /ulstrongRequirements:br/strongulliBS degree or equivalent, in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy). /lili6-8 years clinical trial management experience in the pharmaceutical industry or CRO. Specific therapeutic area experience. /liliStrong working knowledge of ICH-GCP, local laws and regulations. /liliSuperior clinical research operational knowledge. Proven track record in successfully managing various aspects of trials from start-up to database lock and trial closure. /liliDemonstrated effective leadership to proactively drive the Study Management Team through key stages of trials, as well as delegation skills. /liliEffective leadership skills and ability to manage multiple stakeholders. /liliProven ability to lead a team through formation stages, up to operating as a high performing team. /liliExperience and ability in coordinating global or regional teams in a virtual environment. Proven ability to foster team productivity and cohesiveness. /liliExperience and ability in coordinating global teams in a virtual environment for a minimum of 2, preferably 3 years. /liliProven experience in proactive planning, risk mitigating and gaining team consensus on updated plans during the project lifecycle. /liliStrong project planning/management. /liliIndependent complex decision making. /liliSolution oriented and proactive risk identification and mitigation. /liliStrong IT skills, including knowledge of standard Microsoft applications, Trial Master File, Clinical Trial Management System, and willingness to learn new systems. /liliMonitoring experience is recommended, or other relevant experience should be considered, such as data management or central monitoring. /liliTravel. /liliProficient in speaking and writing local country language and English. /liliEffective verbal and written communication skills leading to successful team collaboration /liliStrong decision making. Solution oriented. /liliStrong analytical skills, and simultaneously demonstrates the ability to manage ambiguity when limited information is available. /liliExperience in developing presentations and presenting key information to stakeholders. /liliAbility to understand and competently plan and have oversight of country and select vendor budgeting processes, i.e. Understand and be aware of country Out of Pockets (OOPs) and FTE cost drivers. /liliPlease note This role is not eligible for UK visa sponsorshipbr/li /ulIQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at IQVIA, we believe that diversity, inclusion, and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone, everywhere. When our talented employees bring their authentic selves and their diverse experiences to work, they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multi-talented collaboration harnesses innovation to deliver superior outcomes. /ph3Seniority level /h3ullih3Seniority level /h3Not Applicable /li /ulh3Employment type /h3ullih3Employment type /h3Full-time /li /ulh3Job function /h3ullih3Job function /h3Project Management and Information Technology /lilih3Industries /h3Pharmaceutical Manufacturing /li /ulpReferrals increase your chances of interviewing at IQVIA by 2x /ph3Sign in to set job alerts for “Senior Project Manager” roles. /h3pWe’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. /p #J-18808-Ljbffr