Jobs at IQVIA

Role Summary/Overview:

• This mid-level position provides broad analyst support in the end-to-end design, development, implementation, deployment, and maintenance of robust healthcare data collection and processing systems. These systems are intended for and support critical observational studies, including population health, disease monitoring, clinical trials, and health surveillance. The Business Analyst under general supervision will support the entire lifecycle of these systems, working with product team members to ensure effective analysis and project execution, including data analysis. The goal is to deliver solutions that are efficient, scalable, maintainable, and meet stakeholder needs.

Required Qualifications:

Education & Experience:

• Bachelor's degree in Health Informatics, Computer Science, or a related field (or equivalent experience).
• 2+ years of hands-on experience in business analysis, implementing healthcare-related data and/or processing systems, such as clinical trial management software, LIMS, or EDCs, preferably for observational studies.

Healthcare Data Expertise:

• Proficiency in data modeling (relational and non-relational) and applying various healthcare data models (e.g., HL7 FHIR, OMOP) to solve practical problems.
• Demonstrated knowledge and practical application of healthcare data standards, particularly HL7 (especially FHIR).
• Proven ability to work with, describe, convert, and/or integrate idiosyncratic or custom data models into standard formats.

Technical & Analytical Acumen:

• Experience with business analysis applications for analysis, presentations, and requirements documentation (such as Excel, PowerPoint, Jira, Confluence, Aha, mind mapping or process flow applications).
• Demonstrated ability to understand client requirements as well as underlying infrastructure applications, systems, and processes to enable execution of those skills.
• Proven ability to troubleshoot and resolve complex technical problems in healthcare data systems and integration, with general guidance.
• Strong analytical and problem-solving skills, with a focus on healthcare data challenges.
• Proficiency with distributed version control systems, preferably Git, for collaborative development and documentation.

Communication & Project Management Skills:

• Excellent written and verbal communication skills, capable of explaining moderately complex technical healthcare data concepts clearly and concisely to both technical and non-technical audiences.
• Ability to work independently, balance multiple priorities, and support project teams to successful project completion in the context of healthcare data projects.
• Effective in rapidly producing clear, concise, and accurate standard business documentation and various diagram types (e.g., ERDs, flowcharts, sequence diagrams), understanding the appropriate use for each and the ability to use a combination of multiple diagram types to describe moderately complex business processes accurately and comprehensively.

Healthcare Domain Knowledge:

• Familiarity with the U.S. healthcare system, including its data structures, standards, and key initiatives.
• Experience with data management requirements and considerations for human subjects research, especially longitudinal studies.
• Knowledge of good data management practices for scientific datasets (ensuring integrity, security, and HIPAA compliance).

Adaptability & Learning:

• Demonstrated ability to quickly learn and master new, highly detailed, domain-specific knowledge (e.g., Quality Payment Program) and apply it to implementation projects, becoming a subject matter expert on regularly changing programs.

Key Responsibilities:

• Work with senior analysts and the project manager to execute the full lifecycle of study and registry product implementation projects, supporting their completion on-time, on-budget, and in accordance with stakeholder requirements. Under general direction, formulate and define systems scope and objectives based on both user needs and a good understanding of applicable business systems and requirements.
• Implement real world evidence systems in alignment with product capabilities and client protocols.
• Work collaboratively with epidemiology and data management teams to document product configuration, identify configuration gaps, and apply healthcare data models and standards (e.g., HL7 FHIR, OMOP) under advisement by medical sciences and data analysts.
• Document data collection and integration requirements to meet study and regulatory needs. Assess and prioritize requirements for configuration. Document user stories, maintain good documentation practices, and support engineering teams in executing projects using agile and hybrid methodologies.
• Ensure good data management practices are maintained for healthcare datasets intended for scientific use, maintaining data integrity, security, and HIPAA compliance.
• Project Execution & Solution Delivery: Support the full lifecycle of healthcare data system implementation projects, enabling their completion on-time, on-budget, and in accordance with stakeholder requirements. Identify and triage issues and escalate to higher-level analysts or business team for prioritization.

Data Modeling, Analysis & Management:

• Under general guidance, conduct and document specified data modeling, encompassing both relational and non-relational approaches.
• Perform data analysis to assess data structures and investigate integrity.
• Apply healthcare data models and standards (e.g., HL7 FHIR, OMOP), employing resources and mentors to ensure consistency.
• Accurately interpret, describe, convert, and integrate data from disparate, idiosyncratic, or custom data models into standardized formats.
• Ensure good data management practices for healthcare datasets intended for scientific use, maintaining data integrity, security, and HIPAA compliance.

Technical/Data Problem Solving & Expertise:

• Diagnose, troubleshoot, and resolve technical issues related to data systems to minimize disruptions, ensure data accuracy, and maintain system uptime.
• Stay current with and maintain knowledge of evolving healthcare data standards (e.g., HL7 FHIR, OMOP), models, and technologies, and drive their effective implementation.

Documentation & Communication:

• Create, produce, and maintain clear, concise, and accurate technical and standard business documentation for project processes, procedures, system designs, and solutions to facilitate clarity, reproducibility, and effective knowledge transfer. This includes process flow diagrams, workflow diagrams, sequence diagrams, state flow diagrams, and Entity-Relationship Diagrams (ERDs).
• Consistently and clearly communicate complex technical information to diverse audiences, including cross-functional teams, external stakeholders, customers, and senior leadership, managing expectations appropriately.
• Follow standard operating procedures for quality documentation, including developing business requirements, user stories, acceptance criteria, and system requirement specifications. Show sound professional judgment in employing, verifying, and editing AI content in documentation.
• Collaboration & Integration: Work closely and collaborate effectively with cross-functional teams and external stakeholders to ensure the seamless integration of healthcare data solutions.
• Operational Alignment: Work in alignment with global teams on Central European Time and U.S. Eastern Time.

Preferred Qualifications:

• Standards Mastery: Intermediate proficiency in the use of FHIR and other healthcare data standards.
• Coding Systems: Familiarity with healthcare coding systems (e.g., SNOMED, ICD, LOINC).
• Technical Skills: Practical experience with scripting languages (e.g., Python, R, SAS) and query languages (e.g., SQL) to deliver project outcomes.
• Certifications: Relevant certifications in healthcare informatics or healthcare data standards or technologies (e.g., FHIR certification).
• Domain Experience: Experience in human subjects research, clinical research, public health, or related fields.

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Job Overview

• Manage and support team of Data Management professionals to efficiently produce databases that meet customer requirements.

Essential Functions

• Provide expert review and guidance for production of Data Management deliverables including CRF/e-CRF, database design and set-up, validation definition and programming, Data Management Plan and database deliverables to internal and external customers. Provide technical advice and solutions with internal and external customers to solve problems and improve efficiency. Ensure that staff is trained and compliant with current operating procedures and work instructions and project scope of work. Identify and address professional development/training needs of staff. Mentor staff members to develop Data Management process, system, and drug development expertise. Provide operational input into proposals and scope of work. Participate in proposal defenses.
• Hold at least bi-monthly meetings with direct reports to discuss, at a minimum: project status, including timelines, delivery updates, financial aspects of the group or project, and potential risks, associated mitigation and support required; status of any initiatives that they may be involved in; the team's utilization rates; the direct report's training and other administrative obligations, such as Standard Operating Procedures (SOPs) and corporate training mandates; personnel issues; and career or training objectives.
• Develop and implement plans for measuring and improving employee engagement, ensuring global consistency.
• Collaborate with project leads to address work scheduling for current and projected projects, staffing needs, technological needs, and projected peak workloads, ensuring global consistency, where possible. Develop and manage associated action plans to hold members accountable.
• Efficiently conveying messages from leadership to direct reports and teams, as well as effectively communicating issues and opportunities up to leadership.
• Might be needed to serve as the designated substitute or alternatively ensure coverage is in place for direct reports during their absence or in case of turnover.
• Attend and participate in Bid Defenses, Kick off Meetings (KOM), as applicable. Support Request for Information (RFI), Request for Pricing (RFP), and budgets, as requested.
• Participate / Support internal and external audits and inspections, as required. Also ensure required staff is assigned, trained and prepared to support.

Qualifications

• Bachelor's Degree Clinical, biological or mathematical sciences or related field, or nursing qualification Req
• 7 years of relevant work experience including people management. Equivalent combination of education, training and experience.
• Advanced knowledge of Data Management processes and systems.
• Solid understanding of clinical drug development process and production of Data Management deliverables
• Proven Staff management skills, strong leadership, motivational and influencing skills.
• Strong organizational skills, metrics calculations, and time management skills.
• Strong verbal/written communication skills.
• Ability to work on multiple projects and manage competing priorities effectively
• Effective mentoring and developed coaching skills.
• Ability to achieve results through proactive communication and facilitation in a matrix service delivery environment with shared accountabilities.
• Sound judgment, decision-making and problem-solving skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients
• Ability to follow instructions/guidelines, utilize initiative and work independently.
• Understanding on basic Project Finance (EAC, forecasting, burn-rate monitoring and recognizing & pursuing OOS where appropriate)
• Ability to drive business and financial results – short and long term.
• Ability to proactively evaluate risks and potential issues and seek solutions and discuss appropriately with direct reports, colleagues, and customers.
• Demonstrates good judgement in requesting input from senior staff. When requesting input, ensure clearly laying out the issue and required background details, articulating what support is needed; and what are the recommended actions.

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Job Description

• The CDM will perform scientific (complex) clinical data review in close collaboration with the Study Responsible Physicians (SRP) and Study Responsible Scientists (SRS).

Deliverables:

• Services rendered will adhere tapplicable Client SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc.
• Provides scientific data review support for more than one low tmoderate complexity trial or one high complexity trial.
• The data management expert who, within the therapeutic area, is performing scientific (complex) clinical data review in close collaboration with the Study Responsible Physicians (SRP) and Study Responsible Scientists (SRS). Tapping inttechnical and clinical expertise, closely collaborating with the SRP, SRS, Data Management functions and the rest of the study team members when implementing the data management related activities for protocols, with focus on more complex indication and therapy related elements of the study. Reviews all necessary data flows, the Data Management Plans and performs continuous (complex) data review activities on the studies in the assigned program.
• Involved in study related activities from the protocol design stage onwards, providing input intthe study specific and/or indication specific data collection tools.
• Reviews (complex) scientific study data, manages CDM and SRS/SRP related queries in eDC system and holds discussions with SRS/SRP. Involvement in other review activities (e.g., Coding, SAE reconciliation) is possible. Leads and/or attends meetings as appropriate.
• Takes a leadership role with SRP/SRS and collaborates with the GDM testablish, align and confirm scientific clinical data review expectations for assigned trial(s).
• With the trial customer, CRand other functional partners in relation tCDM related activities:
• Reviews content and integration requirements for eCRF and other data collection tools
• Establishes conventions and quality expectations for clinical data.
• Set timelines and follow‐up regularly tensure delivery of all Clinical Data Management milestones
• Creates the Integrated Review Plan ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency. Reviews related clinical data management documents. Ensures compliance with regulatory guidelines and documentation requirements.
• Ensures real‐time inspection readiness of all assigned deliverables for the trial; participate in Regulatory Agency inspection and Client internal audits as necessary.
• Plans and tracks applicable CDM deliverables. Ensures CDM deliverables are on time.
• Takes a leadership role in collaborating with the SRS/SRP tensure that DM and Therapeutic Area trial needs and deliverables are met.
• Identifies and communicates lessons learned, best practices and frequently asked questions at the trial level.
• Identifies and participates in process, system, and tool improvement initiatives within clinical data management.
• Therapeutic Area  - Oncology, Cardiovascular and Immunology

Education/Experience

• BS/BA degree or higher preferably in Health Sciences, or BS/BA degree or higher with professional clinical experience/exposure.
• 5 years Data management experience. Data Management experience preferably including clinical data review or significant experience with clinical data review. Knowledge in medical terminology would be preferable
• Collaboration with Clinical teams.

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Job Description
Base level role

• Perform comprehensive data management tasks including data review, query generation and query resolution.This may also include, but is not limited to creation of eCRF completion guidelines, entry of test data for eCRF and the Data Review Model, testing of data validation rules, etc.Data Management tasks should be inclusive of Study Start-up, Execution, Database Lock and Close-out.
• Perform ongoing Data Reconciliation of all data streams
• Attend study related meetings/teleconferences
• Perform Study Closeout/Archiving Activities including QC of subject/site Archival CRFs
• Create and provide status/metric reports
• Generate reports on EDC and track cleaning progress
• Manage Freeze / lock of eCRF
• File documentation in the virtual Trial Master File (TMF)
• Receives and enters lab normal ranges

Advance level role

• Provide timely status updates including issues & risks to DM and DMLs as needed
• Act as the Point of contact for Clinical Data Manager, working pro-actively to identify risks and provide mitigations
• May communicate with the vendors to resolve reconciliation issues.
• Provide input to Study set up activities including but not limited to creation of DVRs
• Create and/or provide inputs to Data Management documents (e.g. eCRF completion guidelines, etc.).
• Review and provide inputs to Data Management documents (e.g. IRP, DMP, etc.)
• Assign work to allocated CDAs on a trial.Coordinate work of CDAs assigned to a study working closely with the Global Data Manager to understand priorities and timelines.
• Assist the Data Management Leader in TMF compliance reviews.
• Train and mentor CDA staff
• May serve as an SME and participate in SME forums
• May act as delegate for Data Manager, as needed

Education and Experience Guidelines: 

• Bachelor’s degree in a Health or Science discipline with experience in clinical research.
• Data Management experience and experience working on a clinical trial mandatory.
• Rave experience mandatory
• Experience working in highly diverse teams within clinical research; cross-functional, global, multi- regional.
• Knowledge of current industry standards (e.g., CDISC, SDTM, CDASH, etc.) for Advanced CDA.
• Knowledge of technology platforms and systems to capture and process data
• Project management skills.
• Vendor management skills.
• Proficiency with Microsoft Office tools
• Experience CDA BASE level: 1-3 years of experience.
• Experience CDA ADVANCED level:>3 year of experience