Job Overview
Independently handle complete delivery of data management services for individual or multi-service projects, ensuring deliverables of high quality within the stipulated time and budget, to the satisfaction of the customer. Provide in-depth data management expertise to the Clinical Data Management (CDM) team to deliver high quality data management products that fulfill customer needs. Provide leadership and direction to the team in the areas of project planning, execution and completion, financial management, communications and milestone deliverables. You may perform the role of Data Team Lead (DTL), Program Lead, Customer Site Manager, or a leadership role in a specific CDM task (such as a Subject Matter Expert (SME). You must adhere to Good Clinical Practices (GCPs), related regulatory guidelines, SOPs, policies, and where available, CDM guidance documents.
Essential Functions
• Client Management: Act as the main point of contact for customers on data management deliverables.
• Manage several large-scale studies or programs of studies (possibly global). Provide leadership and senior level support to DTLs on multiple large global studies or a program of global studies.
• Implement project management expertise by working with customer data managers, key decision makers, and internal team members to manage continuous process improvements, escalate issues, project workload projections, and offer technical expertise.
• Lead direct negotiations with customers, such as timelines, finances, processes, resources.
• Maintain strong relationships with customers.
• Ensure open communication with customers and IQVIA management to independently manage and fulfill contractual obligations.
• Service Management:
• Regularly meet with Data Operations Coordinator (DOC) and/or Data Operations team members to ensure timeline adherence and quality deliverables.
• Provide training and development on data management expertise to junior team members.
• Establish robust communications with the Data Operations team, functional leads, project managers and all other stakeholders.
• Independently manage DM service delivery with comprehensive DM process and technical expertise in executing projects.
• Act as the escalation point for unresolved data issues, working independently with client data managers, vendors, and internal team members for resolution.
• Ensure that appropriate resources are allocated to meet project deliverables.
• Create and/or review and sign-off on all data management plan (DMP) documents.
• Ensure service and quality meet the agreed-upon specifications according to the DMP and contract/Statement of Work (SOW).
• Implement proactive quality management plans across multiple projects/programs/customer accounts. Manage service performance and provide leadership to identify the root causes of issues and implement corrective actions.
• Continually look for opportunities to improve service.
• Develop and work with the team to implement plans to reorganize and drive change (possibly across a customer account).
• Ensure timely follow-up and resolution of compliance issues.
• Act as a Subject Matter Expert (SME).
• Provide leadership and expertise in a specific CDM task or technology.
• Serve as a customer site lead for one or more customers.
• Train and mentor junior DTL staff in DM expertise.
• May coordinate the work of more junior DTL staff.
• Independently maintain internal tracking databases and systems.
• Financial Management/Business Development Support:
• Independently manage Statement of Work (SOW)/budget.
• Review financial reports monthly and participate in project reviews as requested.
• Identify tasks outside the scope and track change orders to completion.
• Participate in pricing discussions across the customer accounts.
• Act as Project Manager for single service DM projects, including financial tracking, revenue recognition, and invoicing.
• Independently support the Request for Proposal (RFP) process (review RFP documents, pricing, attend bid defense sessions).
• Other:
• Bring independent process improvement and solutions to the CDM team/CDM department.
• Lead a focal team or global or local best practice team.
• Share lessons learned and/or present in CDM workshops.
• Manage the development and implementation of new technology or tools.
• Present at professional conferences and/or publish articles in professional journals.
• Provide review and expert opinion in the development, revision, and maintenance of core operating procedures and work instructions.
• Carry out other duties as directed by the functional manager.
Qualifications
• Bachelor's Degree in Health, Clinical, Biological or Mathematical sciences, or a related field is required.
• Minimum of 5 years of direct Data Management experience with at least 3 years as a CDM project lead is preferred.
• Previous experience and proven competence in managing the delivery of multiple global trials through the complete DM lifecycle (for instance, large trials of at least 1000 patients) is necessary. Proven data management skills and advanced understanding of the data management process (for instance, specific therapeutic areas, extensive knowledge in DM processes, SAE reconciliation, external data vendor reconciliation, management of local laboratory data, and/or new technology) is required. Previous experience and proven competence in managing complex customer negotiations and bid defense sessions independently is essential. Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology. Knowledge of operating procedures and work instructions and the ability to apply them in practice is necessary. Knowledge of Good Clinical Practices and relevant regulatory guidelines is fundamental. Excellent communication, interpersonal, customer service, and teamwork skills are needed. Excellent organizational and problem-solving skills are required. Excellent project management skills are important. Ability to work independently is key. Comprehensive understanding of the clinical drug development process is needed. The ability to establish and maintain effective working relationships with coworkers, managers, and customers is essential.
IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to create the biggest possible impact - to assist our customers in creating a healthier world. Learn more at [https://jobs.iqvia.com](https://jobs.iqvia.com).