Senior Global Clinical Leader

IQVIA ,
Reading, Berkshire
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Job Description

IQVIA is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward. Real World Evidence Senior Global Clinical Operations Leader Flexible office and homebased locations across Eastern, Central and Southern Europe IQVIA Real-World Evidence (RWE) teams work with clients to help them collect and use real-world data to generate evidence to meet the needs of regulators, payers, providers and patients. IQVIA's Real World Evidence Solutions (RWES) group is recruiting Real World Evidence Associate Site Management Leads (ASML) who are the responsible of having the clinical oversight of a project and have a key lead role by coordinating CRAs and SMs regionally and cross-regions from the start to the close-out of the project. They are RWE Physician Initiated Data Generation experts and they apply clinical research experience and skills to engage site management/monitoring staff to ensure process and practice methodology is applied consistently and in accordance with project scope and budget, SOPs, policies, good clinical practices and applicable regulatory requirements. PURPOSE Lead the execution of the Site & Patient Services (SPS) components of Real World Late Phase Research (RLWPR) studies by applying clinical research expertise, exceptional decision making skills and innovative approaches to problem solving. Proactively set project goals and tangible expectations for SPS project team members. RESPONSIBILIITES * Oversee the execution of Start Up and/or Maintenance for assigned projects in accordance with the agreed Regulatory Start Up strategy. May implement and maintain the Regulatory Start Up Management Plan in accordance with the Scope of Work and Project Plan, within the agreed project strategy. * Manage the operational aspects of projects to achieve "right subjects" and "right data" to meet our contractual requirements. * May participate in bid defense preparations. Attend bid defense presentations and lead the clinical delivery strategy for less complex studies, in partnership with business development and senior project leader as needed. * Ensure collaboration across Site Management Leads, including communication with regions and countries, to successfully deliver the agreed project scope; coach members of the team to ensure timely delivery of projects * Real Word Evidence resource request review and alignment from project award and during entire duration of the project. * Develop and maintain clinical project plans, including but not limited to i. e. Clinical operations plan, Regulatory Start Up Management Plan, etc. to be incorporated into the integrated study management plan/project management plan. * Accountable for the clinical delivery (subject recruitment, site management, data integrity) per contract, ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures. * Partner with the project leaders to confirm objectives of the clinical team according to agreed-upon contract, strategy and approach. Effectively communicate and assess performance against these agreed objectives. * Ensure all appropriate subject/patient recruitment strategies are in place at the outset of the study to maximize subject/patient recruitment opportunities to achieve delivery according to contract, including, but not limited to, all outreach or digital offerings being explored and deployed. * Ensure all processes and tools are available to maximize Site Management team's ability to monitor and secure patient recruitment to the monitoring team from the outset of the study including, but not limited to a clear recruitment strategy plan, the subject/patient pathway materials and clearly defined contingency plans with agreed trigger points for deployment. Throughout the study these strategies and materials should be kept under constant review and updated in response to progress on the study to ensure clear understanding by all parties (internal and external) of expectations throughout the recruitment period; and inspire customer confidence in a clear and enforced action plan and thereby ensure successful delivery to customer satisfaction. * Monitor progress against contract and prepare/present project information proactively to all stakeholders internally and externally as required. * Deliver the project/program according to the quality management plan. Guide Site Managers/Clinical Research Associates (CRAs) and advise on critical specific study issues. * Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles. * Manage risks (positive and negative) which could impac

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