Global Delivery Service Manager

Global 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. 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). 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. May act as the lead over a team of CTMs across a project/program, on insourced and outsourced studies. May contribute to process improvement and/or non-project work.Task:• Services rendered will adhere to applicable to sponsors SOPs, WIs, policies, codes of Good Clinical Practice (GCP), local regulatory requirements, etc.• Complies with relevant training requirements.• Lead the Study Management Team including providing updates to all trial team members on deliverable status.• Ensure availability of required reports to support real time tracking of trial status according to trial plan.• Ensure that the Study Management Team (SMT) operates in a constant state of inspection-readiness.• Act as the primary contact person for the local teams within GCDO.• Contribute to data collection to support the site selection process.• Establish enrollment commitments and ensure actual enrollment meets projected commitments across the regions at the clinical trial level.• Perform Annual Quality Review of files, as appropriate.• Create 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.• Provide 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.• Ensures creation of appropriate trial-specific training materials and requirements, making them available to the regional/site/CRO staff and delivering training as needed.• Establish and maintain excellent working relationships with internal stakeholders, such as country representatives, data management leader and clinical supplies unit.• Work with Bioresearch Quality & Compliance (BRQC) liaisons to ensure quality oversight of assigned trial utilizing the available tools.• Coordinate data cleaning with some supervision towards a timely and successful database lock.• Sufficient therapeutic knowledge to support defined CTM roles and responsibilities.• Contribute to process improvement and training, as applicable.6-8 years clinical trial management experience in the pharmaceutical industry or CRO. Strong working knowledge of ICH-GCP, local laws and regulations.• Proven track record in successfully managing various aspects of trials from start-up to database lock and trial closure.• Demonstrated effective leadership to proactively drive the Study Management Team through key stages of trials, as well as delegation skills.• Experience and ability in coordinating global or regional teams in a virtual environment. Experience and ability in coordinating global teams in a virtual environment for a minimum of 2, preferably 3 years.• Proven experience in proactive planning, risk mitigating and gaining team consensus on updated plans during the project lifecycle.• Strong project planning/management.• Solution oriented and proactive risk identification and mitigation.• Strong IT skills, including knowledge of standard Microsoft applications, Trial Master File, Clinical Trial Management System, and willingness to learn new systems.• Monitoring experience is recommended, or other relevant experience should be considered, such as data management or central monitoring.• Travel.• Proficient in speaking and writing local country language and English.• Please note This role is not eligible for UK visa sponsorshipIQVIA 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 is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. Prague, Czech Republic; Milan, ItalyType: Full time