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ADAM Standards Engineer
IQVIA · Barcelona, ES
Teletreball .
Job Overview
Provide experienced technical expertise to develop process methodology for department to meet internal and external clients’ needs. Plan and coordinate the development of integrated programming solutions serving the full spectrum of statistical programming needs. Provide technical expertise and leadership to the department. Provide internal consulting services, including specifications and user needs analysis for complex project or client requirements.
Essential Functions
- Perform, plan and co-ordinate the following for complex studies: (i) the programming, testing, and documentation of statistical programs for use in creating statistical tables, figures, and listing summaries and (ii) the programming of analysis databases (derived datasets) and transfers of data for internal and external clients. May perform and plan the programming of database quality control checks.
- Program and plan the integration of databases from multiple studies or sources.
- Develop and co-ordinate programming documentation including plans and specifications, as appropriate, for complex studies.
- Provide advanced technical expertise in conjunction with internal and external clients, and independently bring project solutions to teams and department, for complex studies.
- Perform, plan and co-ordinate the development, implementation and validation of new process technologies, macros and applications.
- Fulfill project responsibilities at the level of statstical team lead for single complex studies or group of studies.
- Understand the Scope of Work, budget and quote assumptions, estimate the work completed, manage Out of Scope and resource forecasts for single studies. May manage project budget and resource requirements, and provide revenue forecasts for single studies.
- Provide training and guidance to lower level staff.
- Master's Degree Computer science & Bachelor's Degree Computer science or related field
- Knowledge of statistics, programming and/or clinical drug development process
- Advanced knowledge of computing applications such as Base SAS, SAS Graph and SAS Macro Language
- Good organizational, interpersonal, leadership and communication skills
- Ability to effectively manage multiple tasks and projects
- Excellent accuracy and attention to detail
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
- Actively support both the development and ongoing maintenance of standard ADaM metadata programming.
- Strong understanding of CDISC ADaM datasets and experience in managing ADaM standards
- Hands on experience with P21 for data validation
- Basic knowledge and understanding of eSubmission docs (ADRG, DEFINE)
- Knowledge on Tables listings and figures is an added advantage.
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.
IQVIA
Global Clinical Project Manager - Vendor Management Expert (home-based in Europe)
IQVIA · Madrid, ES
Teletreball . Excel
Global Clinical Project Manager - Vendor Management Expert – Single Sponsor
Are you an experienced Vendor Management professional looking to make an impact in global clinical trials?
We are seeking a Global Clinical Project Manager - Vendor Management Expert to join our Single Sponsor Department. In this role, you 'll become an expert in Vendor Management for global clinical trials across all phases (Phase I–IV), ensuring seamless execution from study start-up through close-out.
What We’re Looking For
To excel in this role, you should bring:
- Global Clinical Project Management experience
- Strong Vendor Management expertise: Central lab, eCOA, IRT, ECG, Imaging, Ancillaries and/or Patient Recruitment & Retention with experience in global clinical trials. (must have experience managing at least 2 of these vendors)
- Deep understanding of clinical operations processes and vendor service categories.
- Excellent project management skills to drive efficiency and collaboration
- Strong communication and influencing abilities to partner effectively across functions.
- Proven ability to manage risk and performance issues in a fast-paced environment
As a Global Clinical Project Manager - Vendor Management Expert, you will be responsible for ensuring vendor deliverables are met with quality and efficiency at the trial level. Your key responsibilities include:
- Vendor Oversight & Coordination – Manage vendor activities across the study lifecycle, ensuring timely and high-quality deliverables.
- Study Start-Up Support – Oversee vendor deliverables during study initiation, ensuring smooth onboarding and activation.
- Risk & Performance Management – Track vendor performance, identify risks, and escalate issues as needed.
- Site Readiness & Activation – Drive vendor activities to support site activations and ensure study milestones are met.
- Study Close-Out – Coordinate vendor deliverables that support Database Lock and study closure.
- Vendor service excellence at the study level
- Vendor onboarding and performance tracking
- KPI (Key Performance Indicator) and KQI (Key Quality Indicator) dashboards to monitor vendor effectiveness
- Site readiness monitoring and documentation
- Risk mapping with contingency planning
- Vendor cost control and oversight
Please note: due to sponsor requirements for the role only candidates based in the listed location/s will be considered. Any applications from candidates based outside of these locations will not be considered
This is an exciting opportunity to play a critical role in global clinical trials, ensuring vendor excellence and operational success. If you’re ready to take on a high-impact role with a leading sponsor, we’d love to hear from you!
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 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.