Clinical Data Management Lead, home-based

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

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.