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

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

Clinical Data Management Lead

Job Description