Overview
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. Oversees vendor compliance at study level.
Essential Functions / Responsibilities
* Accountable for all vendor related operational trial deliverables, according to timelines, budget, operational procedures, quality/compliance and performance standards. Collaborates with the VSM for the VSM’s category specific responsibilities. 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.
* Close interaction and collaboration with study team lead and study team members during study lifetime
* Review of vendor related protocol sections during protocol development
* Collaborate with Vendor startup manager to the development of Study Specification Worksheet (SSW) to facilitate bid process. If no VSM is assigned to the category, drive the SSW completion.
* Manages interface with vendors in cooperation with vendor partner functions
* Quote/proposal review in collaboration with procurement, support contract negotiations, if required
* Contributes to the development of vendor contract amendments
* 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
* Covers all vendor activities after study start-up and all categories not covered by VSMs during start-up
* Initiates/co-ordinates vendor kick-off meeting for categories not covered by VSMs
* Attends vendor kick-off meeting for VSM supported categories
* Optimizing a frontfronted 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
* Manages system and portal user access for vendor, sponsor and site staff, maintain access logs
* Uses Unified Vendor Portal (UVP) to manage vendor
* Uses Clinical Insights to manage vendors and to achieve site readiness timelines
* Plans and tracks supply delivery to sites and return of equipment from sites
* 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
Qualifications
* Bachelor's Degree Life sciences or related field Req
* Requires advanced knowledge of job area, and broad knowledge of a other related job areas, typically obtained through advanced education combined with experience. Req
* Requires 10 years clinical research experience including 6 years of project management experience or equivalent combination of education, training and experience. Req
* 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. Broad protocol knowledge, therapeutic knowledge desired. Good understanding of the competitive environment and how to communicate/demonstrate value through IQVIA solutions.
* Proven track record managing complex studies
* Very good knowledge of clinical trial design and mapping to supplier requirements
* Thorough and technical understanding of specifications for supplier provided services
* User Acceptance testing for eCOA and IRT
* Site collaboration and site activation
* 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.
* Problem solving - Strong problem solving 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. Ability to make decisions, bringing clarity to disparate information to inform actions and drive results.
* 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.
* Prioritisation - Ability to handle conflicting priorities. 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. Demonstrated learning agility and openness to learning and keeping own knowledge and skill set current and evolving.
* 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.
* Finances - Good understanding of project financials including experience managing, contractual obligations and implications.
Please note this role is not eligible for the UK visa sponsorship.
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. Learn more at https://jobs.iqvia.com
Seniority level
* Mid-Senior level
Employment type
* Contract
Job function
* Management and Manufacturing
Industries
* Technology, Information and Internet
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