JOIN US ON OUR EXCITING JOURNEY! IQVIA is The Human Data Science Company, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.
This Clinical Data Team Lead will be responsible for managing end-to-end delivery of data management services for single/multi-service projects, ensuring quality deliverables on time and within budget, to customer satisfaction. Provide comprehensive data management expertise to Clinical Data Management (CDM) team to provide high quality data management products that meet customer needs. Direct the team in areas of project planning, execution and close-out, financial management, communications and milestone deliverables. Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents.
ResponsibilitiesClient Management Serve as primary point of contact for customer on clinical data management deliverablesProvide project management expertise working with customer data managers, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertiseProvide justification for and perform direct negotiations with customer, e.g., timelines, financial, process, resourceMaintain strong customer relationshipsEnsure open communications with customer and Quintiles management to manage and meet contractual obligationsService Management Meet with Data Operations Coordinator (DOC) and/or Data Operations team members on a regular basis to ensure milestones meet timelines and quality deliverablesEstablish strong communications with Data Operations team, functional leads, project managers and all other stakeholdersSupport DM service delivery with comprehensive DM process and technical expertise in executing projectsServe as the escalation point for unresolved data issues; work with client data managers, vendors, and internal team members for resolutionWork with functional manager(s) to ensure appropriate resources are assigned to meet project deliverablesCreate and/or review and sign-off on all data management plan (DMP) documentsImplement proactive quality management plans across multiple projects/programmes. Track service performance and provide leadership to identify root causes of issues and implement remedial actionsServe as Subject Matter Expert (SME)Provide leadership and expertise in a specific CDM task or technologyMaintain internal tracking databases and systemsQualificationsBachelor's Degree, or educational equivalent, in health, clinical, biological or mathematical sciences, or related field5+ years direct Clinical Data Management experience in CRO or pharmaceuticals industry, including 3+ years as a CDM project lead; or equivalent combination of education, training and experiencePrevious experience and proven competence in managing delivery of multiple projects through full DM life-cycle (several studies/programmes)Previous experience of handling customer negotiationsKnowledge of Good Clinical Practices and relevant regulatory guidelinesExcellent communication, interpersonal, customer service, and teamwork skillsComprehensive understanding of clinical drug development processAbility to establish and maintain effective working relationships with co-workers, managers and customers
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