Vacancies at IQVIA

Job Description
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

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Job Description

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

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Job Description

• IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients.
• Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

Data Team Lead, home-based

• You’ll be responsible for managing end-to-end delivery of data management services for multi-service projects, ensuring quality deliverables on time and within budget. You will direct the team in areas of project planning, execution, financial management, communications and milestone deliverables.

Main responsibilities

• Provide leadership and vision to the team
• Manage and deliver several large scale, high complexity/non-standard aspect studies across a range of sponsors and Therapeutic areas
• Manage sponsors at both Study and Programme Level
• Manage delivery of areas requiring specific expertise (e.g Process, Finance)
• Ensure milestones meet timelines and quality deliverables
• Provide project management expertise working with customer data managers, key decision makers and internal team members to manage continuous process improvements and provide technical expertise
• Ensure open communications with customer and Quintiles management to manage and meet contractual obligations
• Provide input for and perform direct negotiations with customer
• Establish strong communications with Data Operations team, functional leads, project managers and all other stake holders
• Support DM service delivery with comprehensive DM process and technical expertise in executing projects
• Create and/or review and sign-off on all data management plan (DMP) documents
• Track service performance and provide leadership to identify root causes of issues and implement remedial actions
• Serve as the escalation point for unresolved data issues; work with client data managers, vendors, internal team members for resolution
• Maintain internal tracking databases and systems

Minimum Education & Experience

• Bachelor’s Degree, or educational equivalent, in health, clinical, biological or mathematical sciences, or related field
• Around 5 years direct Data Management experience, including 3 or more years as a Clinical Data Management project lead is preferred
• Ability to maintain strong customer relationships

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• Job Description
• 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

ADVANCED

• Provide timely status updates including issues & risks to GDM and DMLs as needed
• Act as the Point of contact for Global Data Manager/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

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.
• 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 tool
• Highly organized with excellent written and verbal communication.
• Ability to interpret clinical trial data and present trends to clinical trial team on data.
• Experience CDA BASE level: 1-3 years of experience.
• Experience CDA ADVANCED level: >3 year of experience

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Job Description

• The Central Monitoring Reporting Expert is responsible for the comprehensive setup and implementation of data reporting specifications and tools aligned with clinical trial protocols.
• This role supports centralized monitoring by configuring data review platforms using a wide range of data sources, including electronic data capture (eDC), central labs, ECG, imaging, biomarkers, genomics, real-world data, electronic health records, ePROs, wearables, and other digital technologies.
• All activities are conducted in compliance with applicable standard operating procedures, regulatory requirements, and ICH-GCP guidelines.
• Key responsibilities include collaborating with monitoring managers to identify review requirements and methods, executing data review specifications, and implementing review schedules.
• The expert works closely with stakeholders to define, program, and visualize data reporting tools using established standards and templates.
• They review eDC configurations and data transfer agreements (tsDTAs), ensure alignment with clinical programming, and validate test outputs for accuracy and consistency.
• At a more advanced level, the expert manages complex data streams, ensures consistency across programs or delivery units, and identifies opportunities for efficiency through the reuse of specifications.
• They contribute to process and system improvements, share best practices, and provide training, mentoring, and troubleshooting support to peers.
• The role involves collaboration with central monitoring managers, clinical trial teams, data management teams, and various functional experts such as clinical programmers, data managers, biostatisticians, and study leaders.
• External interactions may include technology partners and vendors.

The role

• Liaison with Central Monitoring Managers for outcomes of protocol de-risking for identification of Review Requirements and Review Methods
• Execute deliverables including specifications for data review and reporting tools.
• Implementation of data review requirements and review methods per protocol defined data review schedule,
• Liaise with key data stakeholders to establish the purpose of data reporting tools and requirements for the definition, programming, and visualization of data for each data stream utilizing available standards and templates.
• Create change requests for the definition new reporting specifications or review methods
• Review trial specific eDC configuration and Data Transfer Agreements (tsDTA’s) for documentation of study requirements and methods for reporting and visualization
• Liaise with clinical programming to ensure alignment and agreement of data output and report visualization.
• Review of test output and visualizations to ensure accuracy and consistency with data reporting specifications and/or set-up requirements.
• Executes deliverables for more complex data streams and reporting specifications
• Able to ensure consistency across deliverables for data within a program or delivery unit
• Identifies opportunities for efficiencies in re-use of similar specifications and reporting requirements
• Ability to work more independently with minimal oversight
• Ability to Identify and communicate lessons learned and best practices to colleagues and CP team members to support process optimization
• Participate in process and system improvement initiatives within the Capabilities Center
• Provide training, troubleshooting and mentoring support for peer colleagues

Requirements:

• Minimum of 5 years’ experience managing data in support of clinical research.
• Experience working with complex data structures and reporting specifications
• Demonstrated project management skills
• Experience working with external data e.g., Safety Lab, PK, Simple Biomarkers, ECG, or similar.
• Experience working on clinical trials.
• Experience working in highly diverse teams within clinical research; cross-functional, global,
• Working knowledge of DRM.
• Working knowledge of GCP/ICH guidelines
• Excellent written and verbal communication in English