Job Overview 

Independently manage end-to-end delivery of data products and platforms for single/multi-service projects, ensuring quality deliverables on time and within budget, to customer satisfaction. Provide comprehensive data management expertise to Clinical Data Management (CDM) team to provide high quality data delivery and analytical reporting products that meet customer needs. Provide leadership and vision to the team in the areas of project planning, execution, and close-out; financial management; communications; and milestone deliverables. 

May perform role of Program Lead, Product Manager, and/or a leadership role in a specific CDM task (e.g. Subject Matter Expert (SME)). 

Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents. 

 

Essential Functions 

Client Management 

Serve as primary point of contact for customer on data delivery\reporting product deliverables 

Provide leadership and technical guidance to DTLs supporting multiple large global studies 

Provide project management expertise working with customer data managers, key decision makers, and internal team members to manage data-delivery and analytical reporting product development, continuous process improvements, issue escalation, workload projections, and provide technical expertise 

Lead product\platform requirements-gathering and negotiations with internal and external customers (e.g. business requirements, timelines, financial, process, resources) 

Maintain strong customer relationships 

Ensure open communications with customers and IQVIA management to independently manage and meet contractual obligations 

 

Service Management 

Meet with Data Management team members on a regular basis to ensure milestones meet timelines and quality deliverables 

Provide training and development to team members on use of data delivery/reporting products 

Establish strong communications with Data Management team, functional leads, project managers, and all other stakeholders 

Independently manage data-delivery platform development with business and technical expertise sufficient to satisfy customer and project-specific requirements 

Serve as the escalation point for unresolved issues related to data product functionality and performance 

Independently work with client data managers, vendors, and internal team members for resolution 

Ensure appropriate resources are assigned to meet project deliverables 

Create and/or review and sign-off on controlled documents related to data-delivery product design, modification, testing, deployment, and validation 

Ensure that data-delivery products meet agreed upon specifications per the DMP and contract/SOW 

Implement proactive quality management procedures related to data integrity, completeness, currency, reproducibility, and performance  

Manage service performance and provide leadership to identify root causes of issues and implement remedial actions 

Continuously look for opportunities to improve data delivery products and services 

Develop and work with team to implement plan to re-organize and drive change  

Ensure timely follow-up and resolution of compliance issues 

 

Subject Matter Expert (SME) / Leadership Responsibilities 

Serve as Subject Matter Expert (SME) 

Provide leadership and expertise in a specific CDM task or technology 

Serve as product owner for one or more data-delivery\reporting products 

Train and mentor junior DTL staff in data management and data-delivery best practices 

May coordinate the work of more junior DTL staff 

Independently maintain internal tracking databases and systems 

 

Financial Management / Business Development Support 

Contribute to SOW/budget management related to development of data delivery products and platforms 

Identify out of scope tasks and track change orders to completion 

Assess feasibility of data-delivery product feature development considering budget constraints 

Participate in pricing discussions across customer account 

Serve as Project Manager for single service data delivery\reporting projects 

Support RFP process (participate in review of RFP documents, pricing, attend bid defense) 

 

Other Responsibilities 

Independently bring process improvements and solutions to the CDM team/CDM department 

Lead a focus team or global or local best practice team 

Communicate lessons learned and/or present in CDM workshop(s) 

Manage the development and implementation of new technologies and methodologies 

Present at professional conferences and/or publish articles in professional journals 

Provide review and expert opinion in developing, revising, and maintaining core operating procedures and work instructions 

Perform other duties as directed by the functional manager 

 

Qualifications 

Bachelor’s Degree in health, clinical, biological or mathematical sciences, or related field (Required) 

Master's degree in healthcare informatics, data science, or related field/experience (Preferred) 

5 years of direct Data Management experience with 3 or more years as a CDM project lead (Preferred) 

Demonstrated expert data management skills and advanced knowledge of the data management process (e.g. therapeutic area, extensive knowledge in DM processes (data integration, transformation, and transfer), external data vendor reconciliation, management of laboratory data, and/or new technology) 

Knowledge of medical data in clinical trial, healthcare provider\payee, and government agency contexts  

Knowledge of industry-standard data specifications and data transaction models (e.g. CDISC\SDTM, HL7\FIHR) 

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 the clinical drug development process 

Ability to establish and maintain effective working relationships with coworkers, managers, and customers 

 

 

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 proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

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.

The potential base pay range for this role is The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.