Website IQVIA
Sharing a Vision to Drive Healthcare Forward Healthcare is an industry designed to help humans. As a global community, we continuously invest and commit to advancing human health. To deliver value and real outcomes. To rise to the challenge to find the next breakthrough by making the most of increa… read moresingly limited resources. We are inspired by the potential and propelled by the possibilities. We share the vision to drive healthcare forward. To see how we can help accelerate progress and achievements. Others are developing these medical breakthroughs. We do our part by using breakthroughs in insights, technology and human intelligence to reimagine and deliver ways to help make them a reality. It’s bigger than better clinical trials. Or advances in technologies and analytics. Or faster insights. It’s about exploring a new path to better health outcomes via Human Data Science. It’s about harnessing the power of the IQVIA COREâ„¢ to channel the insights, commercial and scientific depth, and executional expertise that drive maximum value for our customers. Motivated by the industry we help, we’re committed to providing solutions that enable life sciences companies to innovate with confidence, maximize opportunities, and, ultimately, drive human health outcomes forward. Southdown's Ridge Office Park 2nd Floor, Unit 5 Corner Nellmapius & John Vorster Drive Irene Ext. 54 Centurion Pretoria South Africa 0169
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 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 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
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