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 increasingly limited resources.
We are inspired by the potential ...
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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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