Clinical Data Management Lead, home-based

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. They focus on accelerating the development and commercialization of innovative medical treatments to improve patient outcomes and population health worldwide.

• Previous experience and proven competence in managing delivery of multiple global trials through full data management life-cycle (large trials of at least 1000 patients)
• Demonstrated expert data management skills and advanced knowledge of the data management process including therapeutic area, SAE reconciliation, external data vendor reconciliation
• Proven competence in handling complex customer negotiations and bid defense meetings independently
• Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology
• Knowledge of operating procedures and work instructions and ability to apply them in practice
• Knowledge of Good Clinical Practices and relevant regulatory guidelines
• Excellent communication, interpersonal, customer service, and teamwork skills
• Excellent organizational and problem-solving skills
• Excellent project management skills
• Ability to work independently
• 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
• Around 7 years direct Data Management experience, including 5 or more years as a CDM project lead, or equivalent combination of education, training and experience

• Serve as primary point of contact for customer on data management deliverables
• Manage multiple large studies or program of studies (possibly global)
• Provide leadership and senior support to Data Team Leads (DTLs) on multiple large global programs of studies
• 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
• Lead direct negotiations with customer on timelines, financials, process, and resources
• Meet regularly with Data Operations team members to ensure milestones meet timelines and quality deliverables
• Independently manage data management (DM) service delivery with comprehensive DM process and technical expertise
• Serve as escalation point for unresolved data issues
• Ensure appropriate resources are assigned to meet project deliverables
• Create, review, and sign-off on all data management plan (DMP) documents
• Manage 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 clinical data management (CDM) task or technology
• Independently manage statement of work (SOW) and budget
• Independently bring process improvements and solutions to the CDM team/department
• Lead a focus team or global/local best practice team
• Provide review and expert opinion in developing, revising, and maintaining core operating procedures and work instructions

IQVIA maintains a zero tolerance policy for candidate fraud. All information and credentials submitted must be truthful and complete. False statements, misrepresentations, or material omissions during recruitment will result in disqualification or termination in accordance with applicable law.