Process & Project Manager Engineer

Ecolab; Paris; Sur place; EUR 45 000 - 75 000; Plein temps

Résumé du poste

Une entreprise innovante recherche un spécialiste en gestion des données cliniques pour un rôle hybride à Paris. Ce poste implique la rédaction de documents essentiels, la programmation de listings de révision des données en SAS, et l'assurance de livrables de haute qualité conformément aux SOP. Vous serez responsable de la formation et du mentorat des nouveaux employés, tout en collaborant étroitement avec les équipes de projet pour gérer les risques et assurer la conformité. Si vous êtes passionné par l'analyse des données et la recherche clinique, cette opportunité est faite pour vous.

Qualifications

• 4-6 ans d'expérience pertinente avec un Master en informatique ou 6-8 ans avec un Bachelor en biostatistique.
• Connaissances avancées des outils de gestion des données cliniques et des exigences réglementaires.

Responsabilités

• Rédaction de la documentation et programmation des listings de révision des données.
• Collaboration avec l'équipe d'étude et supervision de la conception des CRF.

Connaissances

Gestion de données cliniques

Programmation SAS

Analyse de données complexes

Connaissance des exigences réglementaires

Compétences en communication écrite et orale

Formation

Master en informatique ou domaine connexe

Bachelor en biostatistique ou domaine connexe

Outils

SAS

Outils de capture de données électroniques

SAS Grid

SAS Macro

Description du poste

Job Responsibilities:

• Drafting basic documentation: basic structure, DVP, DMP; DHR.
• eCRF and ePRO designing and testing.
• Programming of Data Review listings (SAS).
• Edition of the Data Review report.
• Basic cleaning conventions programming.
• Quality control of the documentation and programs of junior data managers.
• Database lock and unblinding process.

Required to participate in development and optimization projects for standard data management processes and programs.

Provide and ensure high-quality deliverables according to Standard Operating Procedures (SOPs) and timelines: Development of Case Report Form according to the protocol, Data Management Plan (DMP), Designing and testing a database, Edit Check Plan, SAS programs (R or Python), Data Quality Plan, Data Handling Report.

Knowledge Sharing:

Help study team regarding operational items. Provide training, guidance, and mentorship to lower-level and new staff.

Collaboration:

Collaborate all along with study team: Supervision of CRF design with Epidemiologist and Client, Development of monitoring tools, Review Safety Management Plan with Project Manager, Follow and advise safety collection with EDC, Lead medical coding activities and Free text coding, Handle data review listings and preparation of meeting with statistician, Handle data issue resolutions, Handle lock and unblinding process.

Risk Management:

Identify risks to project delivery and/or quality and spend time proactively avoiding as well as proposing solutions to mitigate risks. When possible, anticipate risks to minimize need for study level escalations.

Communication and Collaborative Work:

Work closely with the Project Team Lead and supervisor to deliver on time, with high quality. Build and maintain effective customer relationships, driving data-management discussions, providing support and/or guidance for statistical activities.

Other Responsibilities:

As defined on an ad-hoc basis by managers. May assist with cross-functional collaboration.

Profile:

Master's degree in Computer Science or related field and 4-6 years relevant experience / Bachelor's degree in Biostatistics or related field and 6-8 years relevant experience; or equivalent combination of education, training, and experience.

Qualifications and Experiences:

• Advanced knowledge of Electronic Data Capture Tools, Clinical Data Management System.
• Advanced knowledge of Base SAS, SAS Grid, SAS Graph, and SAS Macro language.
• Working knowledge of relevant Data Standards (such as Clinical Data Interchange Standards Consortium CDISC / ADaM).
• Ability to integrate and analyze complex data structures.
• Ability to effectively manage multiple tasks and projects.
• In-depth knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Excellent written and oral communication skills including grammatical/technical writing skills.
• Excellent attention and accuracy with details.
• Strong commitment to quality.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

Location:

This is a hybrid role based in Paris or Bordeaux. Applicants must be able to commute to one of the following locations at least 2 days a week.

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 IQVIA Careers.