Senior Clinical Data Manager (all genders)

Merck KGaA, Darmstadt, Germany
Feltham
1 year ago
Applications closed

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A great opportunity has opened within the Data Monitoring, Management and Innovation department to further strengthen our Clinical Data Management team.As a Senior Clinical Data Manager, you will play a crucial role in managing and overseeing clinical data management activities within the organization. You will be responsible for ensuring the integrity, accuracy, and completeness of clinical trial data, while also coordinating a team of clinical data management professionals in a matrix setting. Your roleAccountable for all Clinical Data Management related deliverables in assigned global (Phase I-IIIb) trials of varying complexityDefine and execute risk-based data collection, cleaning and quality assurance strategies for eCRF and external data (including coding) Ensure the accuracy, integrity, and completeness of clinical trial data through comprehensive data review and validation activitiesRepresent Clinical Data Management within the Core Trial Team and serve as key point of contact for the Data Management related tasks in a trial/project/programEnsure quality of clinical database/deliverables (incl. eCRF and external data) as well as submission readiness of the clinical data management deliverables and data packages (e.g. CDISC)Provide project management for all clinical data management related deliverables e.g. planning timelines and resources, risk identification and management, status tracking, internal and external stakeholder management etc Manage and oversee CRO and vendor performance, including participation in selection/assessment and budget management as required, for assigned trial(s)Contribute to the development and maintenance of data management SOPs, work instructions, and best practices. Who you areBachelor's or Master's degree in a scientific or technical discipline, preferably in life sciences, data management, or a related fieldMinimum of 8 years of experience in clinical data management within the pharmaceutical, biotechnology, or healthcare industryCommitted to continuous personal and professional development, and bringing external insights to the role to drive innovation and process improvementDemonstrated ability to lead and oversee end-to-end data management activities within a clinical trial, as well as leading and coordinating global teams in a matrix organizationStrong project management, communication, collaboration, and problem-solving skillsAbility to work proactively and independently on assigned tasks or projects of varying complexity Proficiency in data management systems and tools, including strong knowledge of regulatory requirements, industry standards, and best practices related to clinical data managementExperience with clinical trial data standards, such as CDISC, is preferredEnglish fluent

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