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 ondatadelivery\reporting productdeliverables
Provideleadership andtechnical guidanceto DTLssupportingmultiple large global studies
Provide project managementexpertiseworking with customer data managers, key decision makers, and internal team members to managedata-deliveryandanalyticalreportingproduct development,continuous process improvements, issue escalation, workload projections, and provide technicalexpertise
Leadproduct\platform requirements-gathering andnegotiations withinternal and externalcustomers(e.g.business requirements,timelines, financial, process, resources)
Maintain strong customer relationships
Ensure open communications with customersand IQVIA management to independently manage and meet contractual obligations
Service Management
Meet with DataManagementteam members on a regular basis to ensure milestones meet timelines and quality deliverables
Provide training and developmentto team membersonuse ofdatadelivery/reportingproducts
Establish strong communications with DataManagementteam, functionalleads, project managers, and all other stakeholders
Independently managedata-deliveryplatformdevelopmentwithbusiness andtechnicalexpertisesufficientto satisfycustomer andproject-specific requirements
Serve as the escalation point for unresolvedissuesrelated todataproductfunctionality and performance
Independently work with client data managers, vendors, and internal team members for resolution
Ensureappropriate resourcesare assigned to meet project deliverables
Create and/or review and sign-off oncontrolled documents related todata-delivery productdesign,modification,testing,deployment,andvalidation
Ensurethatdata-deliveryproductsmeet agreed upon specifications per the DMP and contract/SOW
Implement proactive quality managementproceduresrelated to data integrity,completeness,currency,reproducibility,and performance
Manage service performance and provide leadership toidentifyroot causes of issues and implement remedial actions
Continuouslylookfor opportunities to improvedata deliveryproducts andservices
Develop and work with team to implementplanto re-organizeand drive change
Ensuretimelyfollow-up and resolution of compliance issues
Subject Matter Expert (SME) / Leadership Responsibilities
Serve as Subject Matter Expert (SME)
Provide leadership andexpertisein a specific CDM task or technology
Serve asproduct owner for one or more data-delivery\reporting products
Train and mentor junior DTL staff indata management anddata-delivery best practices
May coordinate the work of more junior DTL staff
Independentlymaintaininternal tracking databases and systems
Financial Management / Business Development Support
Contribute toSOW/budgetmanagementrelated to development ofdata delivery products and platforms
Identifyout of scope tasks and track change orders to completion
Assess feasibility of data-delivery productfeaturedevelopmentconsideringbudget constraints
Participate in pricing discussions across customer account
Serve as Project Manager for single servicedata delivery\reportingprojects
Support RFP process (participateinreviewofRFP 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 ofnew technologiesandmethodologies
Present at professional conferences and/or publish articles in professional journals
Provide review and expert opinion in developing, revising, andmaintainingcore operating procedures and work instructions
Perform other duties as directed by the functional manager
Qualifications
Bachelor's Degree in health, clinical,biologicalor 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, andtransfer),external data vendor reconciliation, management of laboratory data, and/ornew technology)
Knowledge ofmedicaldatainclinical trial,healthcareprovider\payee,andgovernmentagency@contexts
Knowledge ofindustry-standarddataspecificationsanddatatransactionmodels(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 toestablishand 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.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
