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SENIOR CLINICAL DATA MANAGER

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TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their clinical development journey. We provide full-service capabilities, resourcing, and Functional Service Provider (FSP) solutions, helping bring life-saving treatments to patients worldwide.Sponsor: You will be dedicated to a global pharmaceutical/biotech leader in innovative drug development, helping to bring life-changing therapies to market.About the Role:We are seeking a seasoned Clinical Data Manager with a strong background in pharmaceutical data standards to join our team. This role requires an expert understanding of CDISC standards and clinical research programming, coupled with the ability to collaborate effectively with stakeholders to achieve high-quality data submissions.Key Responsibilities:Lead programming, analysis, and reporting processes for clinical research data.Ensure compliance with CDISC SDTM and ADaM standards throughout clinical study lifecycles.Collaborate with sponsors on the implementation and optimization of data standards.Manage end-to-end metadata, from data collection to regulatory submission, ensuring adherence to CDISC guidelines.Develop and generate advanced datasets, including Questionnaire Response Datasets (QRS) and composite endpoint datasets for complex event types.Contribute to the development and collection of performance metrics for clinical programming.Required Qualifications and Skills:Experience: 8–13 years in the pharmaceutical industry with a focus on clinical programming.Education: Bachelor’s degree in a relevant field.Technical Expertise:Extensive hands-on experience with CDISC standards, including SDTM, ADaM, and CDASH.Proficient in clinical programming, data management, and standards compliance methodologies.Strong knowledge of GCP/ICH guidelines.Advanced skills in metadata management and data analysis.Regulatory Knowledge: Comprehensive understanding of CDISC guidance documents and implementation guides.Soft Skills:Exceptional written and verbal communication abilities.Proven capacity to present technical concepts effectively to diverse audiences.Strong collaboration skills for working with cross-functional teams and sponsors.Preferred Skills:Experience with composite endpoint datasets involving multiple event types.Familiarity with advanced statistical and clinical programming tools.What We OfferCompetitive compensation for your expertise and contributions.Opportunity to lead high-impact global projects in a collaborative environment.A chance to work with a global organization committed to innovation and patient-focused solutions.Join UsAt TFS HealthScience, we believe in creating solutions that matter, driven by shared values and a commitment to a healthier future. Join our team and be part of a company that values excellence, innovation, and collaboration, as we work together to bring new treatments to patients worldwide.

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Detalles de la oferta

Empresa

TFS HealthScience

Localidad

En toda España

Dirección

Sin especificar - Sin especificar

Fecha de publicación

01/12/2024

Fecha de expiración

01/03/2025

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