Clinical Data Manager H / F

Vallée Sud Grand Paris; Bagneux; Sur place; EUR 45 000 - 75 000; Plein temps

Résumé du poste

Une entreprise innovante recherche un expert en gestion de données pour soutenir la transformation vers des offres basées sur la valeur. Ce rôle clé implique la coordination des activités autour de la collecte et de la gestion des données pour plusieurs programmes, tout en garantissant la qualité et la conformité des processus. Vous travaillerez en étroite collaboration avec des équipes internes et externes pour définir les processus de collecte de données, assurant ainsi que les projets respectent les normes réglementaires. Si vous êtes passionné par l'analyse des données et la gestion de projets dans un environnement dynamique, cette opportunité est faite pour vous.

Qualifications

• Minimum de 8 ans d'expérience en gestion de données dans des études cliniques.
• Compétences en communication et en travail d'équipe essentielles.

Responsabilités

• Fournir une expertise en gestion de données et établir des relations solides.
• Assurer la qualité et la précision des activités de gestion des données.

Connaissances

Gestion de données

Communication

Gestion de projet

Analyse de données

Formation

Master en sciences, science des données ou mathématiques

Outils

eCRF

ePRO

Description du poste

Within the framework of ALSI World Business Line Markets, Strategy & Innovations, the pole Biometry is a pillar of the Evidence & Access department.

The biometry team supports the generation of evidence of the offers from the 5 Programs, namely Sleep Apnea, Ventilation, Diabetes, Oxygen and iNO therapy, by providing biostatistics and data management expertise in international studies.

Your activities will be part of the global transformation towards value-based offers through the valorization of the Group's various data sources for these 5 programs.

In this context, many of the current and upcoming projects require data collection and data management for multiple sources of data, starting from traditional sources of data, such as eCRF for investigational sites, or ePRO for patients, but also from Air Liquide different entities, each of whom with their own structure. You will have a key role in coordinating the activities and involvement of all stakeholders around data, and supervising CRO activities in collaboration with the study teams and the programs teams.

Tasks and Responsibilities

Strategical Responsibilities:

• Provide Data Management expertise and judgment to the programs.
• Establish strong relationships with internal teams.
• Coordinate with Air Liquide entities' data owners to create and improve pathways for data collection and processing for studies.
• Responsible for delivering key elements of studies Data Management and lead the definition of the data collection-related processes in collaboration with internal and external stakeholders.
• Define the planning of Data-Management deliverables in collaboration with cross-functional teams.

Operational Responsibilities:

• Contribute to the Privacy Impact Assessment by describing the data flow of the study.
• Ensure quality, accuracy, and timeliness of Data Management activities conducted internally or outsourced to Contract Research Organizations (CROs).
• Review CROs proposals and budget forecasts regarding the Data Management activities.
• Work in vendor assessments relevant to Data Management and report the results of functional assessments performed by Data Management.
• Ensure the realization, review, and approval of key elements of studies Data Management including, but not limited to:

List of Data to Achieve Study Goals and Database Structure:

• Data Management documents such as Data Management plan, Data Validation Plan, Coding plan, Deviation Plan, Queries, and documentation for independent data/scientific committee meetings or Steering Committees.

Qualifications:

• Master's degree in science, data science, mathematics, or any related field.
• Minimum of 8 years experience in data management related to clinical and real-world studies in an international pharmaceutical and/or health services development environment, including a minimum of 4 years of project management experience.
• Active in proposing ideas, solutions, and alternatives.
• Ability to multi-task on competing projects.
• Excellent communication, interpersonal, and teamwork skills; good listening skills.
• Able to convey technical information adapted to audience context.
• Fluent in English, written and spoken.
• Business-oriented mindset.
• Works according to Standard Operating Procedures, GDPR, and regulatory guidelines.
• Experience in data protection impact assessment is a plus.