Rechercher
Lead Data Manager - Real World Evidence - M/F/D
Qui sommes-nous ?
Pierre Fabre est le 2ème laboratoire dermo-cosmétique mondial, le 2ème groupe pharmaceutique privé français et le leader des produits vendus hors prescription dans les pharmacies en France.
Son portefeuille compte plusieurs franchises médicales et marques internationales dont Pierre Fabre Oncologie, Pierre Fabre Dermatologie, Eau Thermale Avène, Klorane, Ducray, René Furterer, A-Derma, Naturactive et Pierre Fabre Oral Care.
Implanté depuis toujours en région Occitanie, fabricant plus de 95% de ses produits en France, le groupe emploie près de 10 000 collaborateurs dans le monde et distribue ses produits dans quelque 130 pays. Pierre Fabre est détenu à 86% par la Fondation Pierre Fabre, une fondation reconnue d’utilité publique, et secondairement par ses collaborateurs à travers un plan d’actionnariat salarié.
En 2021, Ecocert Environnement a évalué la démarche de responsabilité sociétale et environnementale du Groupe selon la norme ISO 26000 du développement durable et lui a attribué le niveau « Excellence ».
Pierre Fabre est reconnu comme l’un des « Meilleurs Employeurs du Monde 2021 » par Forbes. Notre groupe est classé dans le Top 6 de l’industrie cosmétique et dans le Top 7 de l’industrie pharmaceutique dans le monde. Nous sommes convaincus que notre engagement et notre passion font préserver notre indépendance et vivre notre raison d'être.
Votre mission
Pierre Fabre Laboratories are hiring a highly skilled and experienced Lead Data Manager – Real World Evidence (RWE) to join the Biometry Department, part of the Data Science & Biometry Department, based in Toulouse (Oncopôle) or Boulogne.”
The Lead Data Manager - RWE position requires a strong expertise in the application of data management within the context of RWE studies. The successful candidate will be agile and adaptable, capable of working in a matrix-organized environment where collaboration across Data Management, Programming, and Statistics is essential. Whilst an excellent track record in RWE is a must, the successful candidate will also contribute to clinical trials, including Randomized Controlled Trials (RCTs).
This department supports all drugs being developed by the company. The department encompasses Data Management, Programming, and Statistics, working cohesively to ensure the successful completion of both Randomized Controlled trials and Real-World evidence studies.
Pierre Fabre is a global pharmaceutical company dedicated to the research, development, and commercialization of innovative drugs. Our Biometry Department is integral to our success, providing comprehensive support for all drug development initiatives, including Randomized Controlled Trials (RCTs) and Real-World Evidence (RWE) studies.
Key Responsibilities
- Act as the primary contact internally and externally for all data management-related topics and participate in project/study meetings.
- Contribute to the selection and evaluation of subcontractors, establishing clear requirements and evaluating proposals.
- Participate in the design of studies, including the data management sections of protocols, data collection consistency, and CRF specifications.
- Oversee outsourced data management activities, ensuring adherence to cost, timeline, and data quality requirements.
- Validate deliverables such as Data Management Plan, Data Validation Plan, Data Transfer Specifications, eCRF completion guides, coding instructions, and data review plans.
- Test the eCRF before deployment and during any protocol amendments.
- Monitor targeted data quality control based on risk assessments.
- Monitor the progress of various data management stages, including data entry, data cleaning, coding, external data transfers and reconciliations including SAE.
- Approve SDTM specifications.
- Regularly evaluate the quality of subcontractor services, establish action plans if deviations occur, and discuss corrective measures.
- Participate in data review meetings and validate associated reports.
- Ensure the lock and potential unlock of the database by verifying all prerequisites.
- Provide statisticians with high-quality data for statistical analysis.
- Follow all industry standards, including ensuring that all data management related documentation is included in the electronic Trial Master File (eTMF).
Qui êtes-vous ?
Qualifications - Experience:
- Advanced scientific degree relevant to Data Management (Master's Degree or equivalent).
- At least 6 years of experience in clinical data management within the biotech, pharmaceutical industry, or a CRO.
- Significant experience in managing real world evidence studies.
Mandatory skills
- Knowledge of Good Data Management Practices and regulatory requirements in Europe and the United States.
- Proficiency in data management tools (eCRF in particular Medidata, IRT, ePRO), SAS
- Understanding of data policies, standards, and compliance requirements.
- Understanding of GDPR, data security principles and practices to protect sensitive information (GxP).
- Familiarity with regulatory guidelines (ICH, EMA, FDA, NICE, ENcEPP)
- Excellent written and verbal communication skills in English
- Excellent communication and cooperation skills, with a rigorous and pragmatic approach.
- Creativity, proactivity, rigor, autonomy, and collaborative spirit.
- Strong ability to manage multiple studies simultaneously and maintain organization.
Optional skills
- Experience with data integration tools and techniques.
- Knowledge of data governance principles and practices.
- Knowledge of CDISC CDASH/SDTM standards.
Application Process
Interested candidates should submit their resume and a cover letter detailing their experience and qualifications for this position.
The hiring manager is Benoît Sansas, Biometry Manager.
The Head of the Biometry Department is Guillaume Desachy.
We look forward to welcoming a new member to our dedicated and innovative team at Pierre Fabre.”
Nous sommes convaincus que la diversité est une source d’épanouissement, d’équilibre social et de complémentarité pour nos collaborateurs, nos offres sont donc ouvertes à toutes et tous sans restriction.
Pierre Fabre est le 2ème laboratoire dermo-cosmétique mondial, le 2ème groupe pharmaceutique privé français et le leader des produits vendus hors prescription dans les pharmacies en France.
Son portefeuille compte plusieurs franchises médicales et marques internationales dont Pierre Fabre Oncologie, Pierre Fabre Dermatologie, Eau Thermale Avène, Klorane, Ducray, René Furterer, A-Derma, Naturactive et Pierre Fabre Oral Care.
Implanté depuis toujours en région Occitanie, fabricant plus de 95% de ses produits en France, le groupe emploie près de 10 000 collaborateurs dans le monde et distribue ses produits dans quelque 130 pays. Pierre Fabre est détenu à 86% par la Fondation Pierre Fabre, une fondation reconnue d’utilité publique, et secondairement par ses collaborateurs à travers un plan d’actionnariat salarié.
En 2021, Ecocert Environnement a évalué la démarche de responsabilité sociétale et environnementale du Groupe selon la norme ISO 26000 du développement durable et lui a attribué le niveau « Excellence ».
Pierre Fabre est reconnu comme l’un des « Meilleurs Employeurs du Monde 2021 » par Forbes. Notre groupe est classé dans le Top 6 de l’industrie cosmétique et dans le Top 7 de l’industrie pharmaceutique dans le monde. Nous sommes convaincus que notre engagement et notre passion font préserver notre indépendance et vivre notre raison d'être.
Votre mission
Pierre Fabre Laboratories are hiring a highly skilled and experienced Lead Data Manager – Real World Evidence (RWE) to join the Biometry Department, part of the Data Science & Biometry Department, based in Toulouse (Oncopôle) or Boulogne.”
The Lead Data Manager - RWE position requires a strong expertise in the application of data management within the context of RWE studies. The successful candidate will be agile and adaptable, capable of working in a matrix-organized environment where collaboration across Data Management, Programming, and Statistics is essential. Whilst an excellent track record in RWE is a must, the successful candidate will also contribute to clinical trials, including Randomized Controlled Trials (RCTs).
This department supports all drugs being developed by the company. The department encompasses Data Management, Programming, and Statistics, working cohesively to ensure the successful completion of both Randomized Controlled trials and Real-World evidence studies.
Pierre Fabre is a global pharmaceutical company dedicated to the research, development, and commercialization of innovative drugs. Our Biometry Department is integral to our success, providing comprehensive support for all drug development initiatives, including Randomized Controlled Trials (RCTs) and Real-World Evidence (RWE) studies.
Key Responsibilities
- Act as the primary contact internally and externally for all data management-related topics and participate in project/study meetings.
- Contribute to the selection and evaluation of subcontractors, establishing clear requirements and evaluating proposals.
- Participate in the design of studies, including the data management sections of protocols, data collection consistency, and CRF specifications.
- Oversee outsourced data management activities, ensuring adherence to cost, timeline, and data quality requirements.
- Validate deliverables such as Data Management Plan, Data Validation Plan, Data Transfer Specifications, eCRF completion guides, coding instructions, and data review plans.
- Test the eCRF before deployment and during any protocol amendments.
- Monitor targeted data quality control based on risk assessments.
- Monitor the progress of various data management stages, including data entry, data cleaning, coding, external data transfers and reconciliations including SAE.
- Approve SDTM specifications.
- Regularly evaluate the quality of subcontractor services, establish action plans if deviations occur, and discuss corrective measures.
- Participate in data review meetings and validate associated reports.
- Ensure the lock and potential unlock of the database by verifying all prerequisites.
- Provide statisticians with high-quality data for statistical analysis.
- Follow all industry standards, including ensuring that all data management related documentation is included in the electronic Trial Master File (eTMF).
Qui êtes-vous ?
Qualifications - Experience:
- Advanced scientific degree relevant to Data Management (Master's Degree or equivalent).
- At least 6 years of experience in clinical data management within the biotech, pharmaceutical industry, or a CRO.
- Significant experience in managing real world evidence studies.
Mandatory skills
- Knowledge of Good Data Management Practices and regulatory requirements in Europe and the United States.
- Proficiency in data management tools (eCRF in particular Medidata, IRT, ePRO), SAS
- Understanding of data policies, standards, and compliance requirements.
- Understanding of GDPR, data security principles and practices to protect sensitive information (GxP).
- Familiarity with regulatory guidelines (ICH, EMA, FDA, NICE, ENcEPP)
- Excellent written and verbal communication skills in English
- Excellent communication and cooperation skills, with a rigorous and pragmatic approach.
- Creativity, proactivity, rigor, autonomy, and collaborative spirit.
- Strong ability to manage multiple studies simultaneously and maintain organization.
Optional skills
- Experience with data integration tools and techniques.
- Knowledge of data governance principles and practices.
- Knowledge of CDISC CDASH/SDTM standards.
Application Process
Interested candidates should submit their resume and a cover letter detailing their experience and qualifications for this position.
The hiring manager is Benoît Sansas, Biometry Manager.
The Head of the Biometry Department is Guillaume Desachy.
We look forward to welcoming a new member to our dedicated and innovative team at Pierre Fabre.”
Nous sommes convaincus que la diversité est une source d’épanouissement, d’équilibre social et de complémentarité pour nos collaborateurs, nos offres sont donc ouvertes à toutes et tous sans restriction.
Publiée le 13/01/2025
