# Global Trial Delivery Manager **Company**: IQVIA **Experience**: senior **Job type**: full-time **Category**: Healthcare **Industry**: Healthcare **Apply**: https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Reading-Berkshire-United-Kingdom/Global-Senior-Trial-Delivery-Manager---Sponsor-Dedicated_R1539790-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply **Canonical**: https://yubhub.co/jobs/job_20cb1e7f-842 ## Description We are seeking a Global Trial Delivery Manager to provide global coordination of clinical trial management activities for internally managed and/or outsourced trials. You will lead the Study Management Team (SMT) and ensure global clinical operations deliverables progress according to agreed upon timelines and milestones. Responsibilities: - 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 - Manage timely and accurate documentation and communication of trial progress - Ensure that the Study Management Team operates in a constant state of inspection-readiness - Act as primary contact for Country and Regional staff - Partner with the Global Trial Lead to execute and oversee central activities from planning, trial start-up, through the life of trial to close-out - Ensure issue escalation and drive issue resolution - Work closely with Trial Team to ensure CAPAs are resolved timely - Contribute to data collection to support the site selection process - Participate in feasibility, providing recommendations as needed - Establish enrollment commitments and ensure actual enrollment meets projected commitments across the regions at the clinical trial level - Ensure the availability of robust recruitment/contingency plans are in place for each region - Ensure timely tracking and filing in appropriate systems, as required at central trial oversight level - Perform Annual Quality Review of files, as appropriate - Ensure archiving and retention of documents per set requirements - Establish country budgets and monitor actuals vs. forecast for Out-of-Pocket Expenses - Oversight of selected vendors and status of related deliverables - Review and approve assigned vendor invoices/spend - Monitor budgets and expenditures as expected per planned trial budget - Create and update trial-specific documents as required - Provide input into cross-functional documents such as safety-related documents, protocol deviations and issue escalation processes - Provide central documents required for HA/EC/IRB submission - Ensure creation of appropriate trial-specific training materials and requirements - Responsible for the set-up, coordination, attendance, and participation of Investigator Meetings - Establish and maintain excellent working relationships with internal stakeholders - Demonstrate deep knowledge of protocol and procedures and adequate therapeutic area knowledge - Ensure compliance with Health Authority regulations and guidelines and internal standard operating procedures and processes - Participate in preparation for, and conduct of, Health Authority inspections and internal audits - Work with Bioresearch Quality & Compliance (BRQC) liaisons to ensure quality oversight of assigned trial - Coordinate data cleaning with some supervision towards a timely and successful database lock - Act as central expert for assigned protocol(s) - Contribute to process improvement and training, as applicable Requirements: - BS degree or equivalent, in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy) - 6-8 years clinical trial management experience in the pharmaceutical industry or CRO - Specific therapeutic area experience - Strong working knowledge of ICH-GCP, local laws and regulations - Superior clinical research operational knowledge - 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 - Effective leadership skills and ability to manage multiple stakeholders - Proven ability to lead a team through formation stages, up to operating as a high-performing team - Experience and ability in coordinating global or regional teams in a virtual environment - Proven ability to foster team productivity and cohesiveness - 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 - Independent complex decision-making - Solution-oriented and proactive risk identification and mitigation - Strong IT skills, including knowledge of standard Microsoft applications, Trial Master File, Clinical Trial Management System - Monitoring experience is recommended, or other relevant experience should be considered - Travel - Proficient in speaking and writing local country language and English - Effective verbal and written communication skills leading to successful team collaboration - Strong decision-making - Strong analytical skills, and simultaneously demonstrates the ability to manage ambiguity when limited information is available - Experience in developing presentations and presenting key information to stakeholders - Ability to understand and competently plan and have oversight of country and select vendor budgeting processes ## Skills ### Required - ICH-GCP - Clinical Trial Management - Leadership - Project Planning - Risk Management - Communication - Analytical Skills ### Nice to have - Monitoring Experience - Data Management - Central Monitoring --- Source: [Apply at iqvia.wd1.myworkdayjobs.com](https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Reading-Berkshire-United-Kingdom/Global-Senior-Trial-Delivery-Manager---Sponsor-Dedicated_R1539790-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)