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
  

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