Lead Data Manager – Real World Evidence – M/F/D

Job title:

Lead Data Manager – Real World Evidence – M/F/D

Company

Pierre Fabre

Job description

Who we are ?Pierre Fabre is the 2nd largest dermo-cosmetics laboratory in the world, the 2nd largest private French pharmaceutical group and the market leader in France for products sold over the counter in pharmacies.Its portfolio includes several medical franchises and international brands including Pierre Fabre Oncologie, Pierre Fabre Dermatologie, Eau Thermale Avène, Klorane, Ducray, René Furterer, A-Derma, Naturactive, Pierre Fabre Oral Care.Established in the Occitanie region since its creation, and manufacturing over 95% of its products in France, the Group employs some 10,000 people worldwide. Its products are distributed in about 130 countries. 86% of the Pierre Fabre Group is held by the Pierre Fabre Foundation, a government-recognized public-interest foundation, while a smaller share is owned by its employees via an employee stock ownership plan.In 2019, Ecocert Environment assessed the Group’s corporate social and environmental responsibility approach in accordance with the ISO 26000 sustainable development standard and awarded it the “Excellence” level.Pierre Fabre is recognized as one of the “World’s Best Employers 2021” by Forbes. Our group is ranked in the Top 3 in the cosmetics industry and in the Top 10 in the pharmaceutical industry worldwide.Your missionPierre Fabre Laboratories are hiring a highly skilled and experienced Senior Data Manager – Real World Evidence to join the Biometry Department based in Toulouse (Oncopôle).The Senior 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).

Who you are ?

• 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.

We are convinced that diversity is a source of fulfillment, social balance and complementarity for our employees, which is why our offers are open to all, without restriction.

Expected salary

Location

Langlade, Gard – Toulouse

Job date

Tue, 10 Dec 2024 08:22:35 GMT

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