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Core member of the Clinical Trial Team (CTT), independently managing all vendor-related aspects of global clinical trial(s) to deliver study outcomes within schedule, budget, quality/compliance and performance standards. Accountable for vendor service delivery at study level. Collaborates closely with the Vendor Start-up Manager (VSM) for selected services (central labs, electronic clinical outcomes assessment/electronic patient reported outcomes (eCOA/ePRO), interactive response technology (IRT), cardiac and respiratory diagnostics, patient recruitment and retention (PR&R), and imaging reading) during study start-up, and leverages effectively their technical and study start-up (SSU) expertise to ensure a timely study start-up. Proactively manages vendor-related risks and potential issues. Implements global vendor strategy and if required, escalates vendor issues to the VSM while keeping Vendor Program Leads informed about risks, issues, and study progress. Accountable for all vendor related operational trial deliverables, according to timelines, budget, operational procedures, quality/compliance and performance standards. Responsible for all activities for which no VSM is assigned with, and for all of the service deliveries after Study Start-up when the VSM is no longer assigned to the study.
Collaborate with Vendor startup manager to the development of Study Specification Worksheet (SSW) to facilitate bid process. Quote/proposal review in collaboration with procurement, support contract negotiations, if required
• Accountable for vendor cost control, budget review, invoice reconciliation and PO close-out
• Vendor service excellence at study level, ensures vendors meet quality and service level standards in their service delivery for the trial
• Attends vendor kick-off meeting for VSM supported categories
• Optimizing a frontloaded and timely study-start-up process, manages vendor-related activities for DB go live
• Performs user-acceptance testing (UAT) for eCOA and IRT
• Drives and monitors central vendor-related activities for site activation, compiles Final Protocol Package (FPP) required documents centrally, monitors site activation progress and addresses related issues and risk
• Creates and maintains vendor-related risk maps with contingency plan for documentation in FIRST
• Interacts and collaborates with Data Ops, reviews vendor-related cycle times (e.g. DTS finalization, data transfers, DBL)
• Acts as escalation point for vendor-related query management
• Follow-up with countries and hubs for their vendor-related risks and issues
• Document issues identified with vendor oversight/performance in FIRST tool and implements and monitors corrective action
Bachelor's Degree Life sciences or related field Req
• Requires 10 years clinical research experience including 6 years of project management experience or equivalent combination of education, training and experience. Knowledge of clinical trials - Knowledge of clinical trial conduct and skill in applying applicable clinical research regulatory requirements i.e. ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct. Thorough and technical understanding of specifications for supplier provided services
• User Acceptance testing for eCOA and IRT
• Vendor management; outsourcing, contracting, sourcing, of clinical services
• Communication - Strong written and verbal communication skills including good command of English language Strong presentation skills. Requires strong negotiation and customer management skills.
• Leadership - Ability to work through others to deliver results to the appropriate quality and timeline metrics, monitoring/managing performance and providing feedback, experience productively partnering cross functionally and with customers to advance work effectively and efficiently. Organisation - Planning, time management and prioritization skills Ability to organize resources needed to accomplish tasks, set objectives and provide clear direction to others, experience planning activities in advance and taking account of possible changing circumstances.
• Ability to work strategically to realize project goals, identifying and developing positive and compelling visions for the successful delivery of the project.
• Quality - Attention to detail and accuracy in work.
• Quality - Results-oriented approach to work delivery and output. IT skills - Good software and computer skills, including MS Office applications including but not limited to Microsoft Word, Excel and PowerPoint.
• Collaboration - Ability to establish and maintain effective working relationships with co-workers, managers and clients. Excellent customer service skills and demonstrated ability to understand customer needs. Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues.
• Cross-collaboration - Ability to work across geographies displaying high awareness and understanding of cultural differences Good understanding of other IQVIA functions and their inter-relationship with Project Leadership.
• of project financials including experience managing, contractual obligations and implications.
• Audit & inspection readiness and management
• IQVIA 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.