Background

IQVIA, formerly Quintiles and IMS Health, Inc.,is an American multinational company serving the combined industries of health information technology and clinical research. It is a provider of biopharmaceutical development and commercial outsourcing services, focused primarily on Phase I-IV clinical trials and associated laboratory and analytical services,...

Responsibilities

• 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
• 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
• 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

• 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
• 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
• Provide leadership and expertise in a specific CDM task or technology
• Maintain internal tracking databases and systems

• 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

• 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