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Clinical Data Manager

3 months ago

Reading, United Kingdom IQVIA Full time

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.

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 sign-off 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

Bachelor’s Degree, or educational equivalent, in health, clinical, biological or mathematical sciences, or related field 5+ years direct Clinical Data Management experience inCRO 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 life-cycle (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 co-workers, managers and customers

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at