Database Delivery and Oversight Lead

il y a 1 semaine


Courbevoie, Île-de-France IQVIA Argentina Temps plein

This unique role within IQVIA lends itself to a technically minded Project Manager with strong communication skills and SDTM knowledge.

Having experience with SAS programming will also be a huge benefit. The role can be based remotely from anywhere in Europe.

This role is part of a sponsor dedicated project where you will be working with the client directly to manage Database Delivery from external vendors.

The primary functions of this role will be to build study eCRFs in Formedix, define structure of datasets that are part of data transfer specifications and ensure quality and completeness of SDTM format data.


Main responsibilities include:
Collaborate with Sponsor colleagues and CRO Partners to finalize the design, creation and implementation of EDC solutions
In collaboration with Study Data Leads ensure the planning for data receipt and its oversight throughout the duration of assigned clinical trials

Process data loads from various sources into the clinical and operational data repositories including the review and communication of issues.

Program reports and contribute to the standardization of process and reports used for data review and analysis for external partners/vendors and internal teams
Complete formal and ad-hoc analyses and oversight of SDTM data.
Review of critical document/deliverable (SDTM Annotation, SDTM datasets) to ensure Data Standards are used consistently and support creation of DE dataset
Attend meetings as applicable with Mission, Submission, Project, Program, JCST, DEM, Biometrics, Clinical & Regulatory Solutions Team (CRST), Early Phase
Perform relevant quality checks and create standard edit checks for new CRF modules and share in the appropriate space
Support audits and inspections as required and other responsibilities and projects that the Company may assign.

Experience:
At least 5 years relevant experience in relational database design
2-3 years SAS experience preferred

Experience with Data Management processes, to include:
Review of SDTM annotated CRFs
Writing and reviewing technical specifications
Review of log files for errors and warnings
Resolving/trouble shooting errors
Experience with data mapping and SDTM Controlled Terminology
Prior experience in a clinical or pharmaceutical related field is required.
Prior experience in a Data Management related field is required
Experience with relational databases, preferably Clinical Data Management and EDC Systems
Advanced familiarity with reporting tools.
Advanced knowledge of federal regulations, Good Clinical Practice, and Good Clinical Data Management Practices.
Excellent command, both verbal and written, of English

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry.

We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world.

Learn more at #J-18808-Ljbffr

  • Courbevoie, Île-de-France Fujitsu Temps plein

    Fujitsu is looking for a Senior Service Delivery Manager who will be reporting to the Head of Global Delivery France.In this position, you will be fully accountable for the delivery and fulfilment of all contracted services with the customer, including full P&L achievement, as well as for their alignment with the contract in terms of agreed Service Level...

  • HBCE Head of FC Oversight

    il y a 1 semaine


    Courbevoie, Île-de-France HSBC Temps plein

    At HSBC, we are an esteemed global organization with a diverse customer base spanning 39 million individuals worldwide across 62 countries and territories. Our vision in Europe is to establish ourselves as the premier international wholesale bank, and we are looking for talented individuals like yourself to help turn that vision into reality. Whether you...

  • SAP Service Delivery Manager

    il y a 1 semaine


    Courbevoie, Île-de-France ENGIE Temps plein

    Come join one of the most ambitious Transformation Program of Engie ENGIE's strategy to drive the energy transition and to industrialize the company, making it simpler, faster, and more integrated, is set. GET, Global Enterprise Transformation, is the Program decided by ENGIE to accelerate and standardize the ERP system as well as the effectiveness of...

  • SAP Service Delivery Manager

    il y a 1 semaine


    Courbevoie, Île-de-France ENGIE Temps plein

    Come join one of the most ambitious Transformation Program of Engie ENGIE's strategy to drive the energy transition and to industrialize the company, making it simpler, faster, and more integrated, is set. GET, Global Enterprise Transformation, is the Program decided by ENGIE to accelerate and standardize the ERP system as well as the effectiveness of...


  • Courbevoie, Île-de-France HSBC Group Temps plein

    At HSBC, we're a trusted international organization with a global customer base of around 39 million customers worldwide through a network that covers 62 countries and territories. In Europe, our ambition is to become the leading international wholesale bank and we need talent like you to help us meet our ambition. Whether you want a career that could take...

  • Digital leader h/f

    il y a 1 semaine


    Courbevoie, Île-de-France BYD Europe Temps plein

    Established in February 1995, BYD Group is a leading multi-sector high-tech company focused on the innovation and development in automobiles, rail transit, renewable energy, and electronics. Committed to fulfilling a better life through technological innovations, BYD Group leverages a powerful network of over 40 subsidiaries and 700,000 employees worldwide...

  • SAP Middleware Lead M

    il y a 1 semaine


    Courbevoie, Île-de-France ENGIE Temps plein

    Therefore, GET Program is among the top 5 ENGIE priorities with genuine ExCom sponsorship.BE part of the Change and come build the Future at one of the most ambitious Transformation Program of the moment.With a view to harmonization, ENGIE has embarked on a major program to transform its processes and IT tools. This project, which extends over several years,...

  • SAP Middleware Lead

    il y a 1 semaine


    Courbevoie, Île-de-France ENGIE Temps plein

    Come join one of the most ambitious Transformation Program of Engie ENGIE's strategy to drive the energy transition and to industrialize the company, making it simpler, faster, and more integrated, is set. GET, Global Enterprise Transformation, is the Program decided by ENGIE to accelerate and standardize the ERP system as well as the effectiveness of...

  • SAP Middleware Lead

    il y a 1 semaine


    Courbevoie, Île-de-France ENGIE Temps plein

    Come join one of the most ambitious Transformation Program of Engie ENGIE's strategy to drive the energy transition and to industrialize the company, making it simpler, faster, and more integrated, is set. GET, Global Enterprise Transformation, is the Program decided by ENGIE to accelerate and standardize the ERP system as well as the effectiveness of...

  • Qrm Project Manager

    il y a 1 semaine


    Courbevoie, Île-de-France MAZARS Temps plein

    Company DescriptionThe Forvis Mazars network, which will be launched on 1 June, will be a Top 10 global network of accountancy and consulting firms. The Quality & Risk Management (QRM) Project Manager will be responsible for leading and managing projects within the QRM domain of Forvis Mazars network.The Quality & Risk management Committee sets up policies...


  • Courbevoie, Île-de-France BYD Europe Temps plein

    About BYD Group Established in February 1995, BYD Group is a leading multi-sector high-tech company focused on the innovation and development in automobiles, rail transit, renewable energy, and electronics. Committed to fulfilling a better life through technological innovations, BYD Group leverages a powerful network of over 40 subsidiaries and 700,000...


  • Courbevoie, Île-de-France ENGIE Temps plein

    We are working in three main development areas : industrial uses, mobility and hydrogen as an energy vector, for which we are developing solutions, large-scale production projects, entering into partnerships and exploring various innovative technologies.We combine the expertise of our teams internationally to develop a wide range of solutions on an...

  • QRM Project Manager

    il y a 1 semaine


    Courbevoie, Île-de-France Mazars Temps plein

    Company Description The Forvis Mazars network, which will be launched on 1 June, will be a Top 10 global network of accountancy and consulting firms. The Quality & Risk Management (QRM) Project Manager will be responsible for leading and managing projects within the QRM domain of Forvis Mazars network. This new role involves collaborating closely with...


  • Courbevoie, Île-de-France ENGIE Temps plein

    Come join one of the most ambitious Transformation Program of Engie ENGIE's strategy to drive the energy transition and to industrialize the company, making it simpler, faster, and more integrated, is set. GET, Global Enterprise Transformation, is the Program decided by ENGIE to accelerate and standardize the ERP system as well as the effectiveness of...

  • Global Operations Manager

    il y a 1 semaine


    Courbevoie, Île-de-France Fujitsu Temps plein

    Global Service Delivery Manager, Operations - Fujitsu FranceBackground: Fujitsu France's outsourcing contract with a major worldwide luxury goods retail company, present in 120 countries, has been extended until 2026.Our client supports end-users for each country with IT infrastructure services that comply with the following rules and principles: All DC...

  • Delivery Center Manager

    il y a 1 semaine


    Courbevoie, Île-de-France ENGIE Global Markets S.A.S. Temps plein

    Requisition ID: 7117- Location: COURBEVOIE, FR, 92400About US (GEMS):ENGIE Global Energy Management & Sales (GEMS) provides energy supply solutions and risk management services to support its clients through their decarbonization journey, while optimizing ENGIE's assets and contributing to value creation.ENGIE is a global reference in low-carbon energy and...

  • Team Leader

    il y a 1 semaine


    Courbevoie, Île-de-France ENGIE Global Markets S.A.S. Temps plein

    Requisition ID:Location: COURBEVOIE, FR, 92400About US (GEMS):ENGIE Global Energy Management & Sales (GEMS) provides energy supply solutions and risk management services to support its clients through their decarbonization journey, while optimizing ENGIE's assets and contributing to value creation.ENGIE is a global reference in low-carbon energy and services...

  • Clinical Trial Manager

    il y a 1 semaine


    Courbevoie, Île-de-France IQVIA Temps plein

    Clinical Trial ManagerGlobal or Regional Applicability: RegionalTrial Management services provide local management of a clinical trial (s) (or Medical Affairs data generation activity) in a country or countries. Services/deliverables include operational oversight of assigned project(s) at the country level for end-to-end project management from start-up...

  • Business Analyst

    il y a 1 semaine


    Courbevoie, Île-de-France ENGIE Global Markets S.A.S. Temps plein

    Requisition ID: 9639- Location: COURBEVOIE, FR, 92400Organization(few words about the division/ department/team)Within the GEMS IS organization, Trading and Sales Tools (Pre-Trade) delivery center is in charge to accompany business entities on their pre-trade IT needs.Teams are covering the following topics:Market connectivity services Automated trading...

  • Cfsp Cpm

    il y a 1 semaine


    Courbevoie, Île-de-France IQVIA Temps plein

    Job OverviewProject Leads are an integral part of clinical trial delivery, liaising with clinical teams to improve patients' lives by bringing new drugs to the market faster. The Project Lead is an essential member of the core project team responsible for project delivery of clinical studies to meet contractual requirements in accordance with SOPs, policies...