Clinical Data Management Lead

2 weeks ago

Dublin, Dublin City, Ireland IQVIA Full time

Clinical Data Management Lead role at IQVIA

Responsibilities
  • 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 DTLs on multiple large global programs of global 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, e.g., timelines, financial, process, resources
  • Meet with Data Operations team members on a regular basis to ensure milestones meet timelines and quality deliverables
  • Independently manage DM service delivery with comprehensive DM process and technical expertise in executing projects
  • Serve as the escalation point for unresolved data issues
  • Ensure appropriate resources are assigned to meet project deliverables
  • Create and/or 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 CDM task or technology
  • Independently manage SOW/budget
  • Independently bring process improvements and solutions to the CDM team/CDM department
  • Lead a focus team or global or local best practice team
  • Provide review and expert opinion in developing, revising, and maintaining core operating procedures and work instructions
Required Knowledge, Skills And Abilities
  • Previous experience and proven competence in managing delivery of multiple global trials through full DM life-cycle (i.e. large trials of at least 1000 patients)
  • Demonstrated expert data management skills and advanced knowledge of the data management process (e.g., therapeutic area, extensive knowledge in DM processes, SAE reconciliation, external data vendor reconciliation)
  • Previous experience and 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 the 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
Minimum Required Education And Experience
  • 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

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