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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 endtoend delivery of data management services for single/multiservice 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 and closeout financial management communications and milestone deliverables. Comply with Good Clinical Practices (GCPs) applicable regulatory guidelines SOPs policies and where available CDM guidance documents.

Responsibilities

Client Management

• Serve as primary point of contact for customer on clinical data management deliverables
• Provide 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 expertise
• Provide justification for and perform direct negotiations with customer e.g. timelines financial process resource
• Maintain strong customer relationships
• Ensure open communications with customer and Quintiles management to manage and meet contractual obligations

Service Management

• Meet with Data Operations Coordinator (DOC) and/or Data Operations team members on a regular basis to ensure milestones meet timelines and quality deliverables
• Establish strong communications with Data Operations team functional leads project managers and all other stake holders
• Support DM service delivery with comprehensive DM process and technical expertise in executing projects
• Serve as the escalation point for unresolved data issues; work with client data managers vendors and internal team members for resolution
• Work with functional manager(s) to ensure appropriate resources are assigned to meet project deliverables
• Create and/or review and signoff on all data management plan (DMP) documents
• Implement proactive quality management plans across multiple projects/programme. Track service performance and provide leadership to identify root causes of issues and implement remedial actions
• Serve as Subject Matter Expert (SME)
• Provide leadership and expertise in a specific CDM task or technology
• Maintain internal tracking databases and systems

Qualifications

• Bachelors Degree or educational equivalent in health clinical biological or mathematical sciences or related field
• 5 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 experience
• Previous experience and proven competence in managing delivery of multiple projects through full DM lifecycle (several studies/programmes)
• Previous experience of handling customer negotiations
• Knowledge of Good Clinical Practices and relevant regulatory guidelines
• Excellent communication interpersonal customer service and teamwork skills
• Comprehensive understanding of clinical drug development process
• Ability to establish and maintain effective working relationships with coworkers managers and customers

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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