Position Title Clinical Data Manager Location New Jersey, NJ Position Type Full Time Overview Eviden is an Atos Group business with an annual revenue of circa € 5 billion and a global leader in data-driven, trusted and sustainable digital transformation. As a next generation digital business with worldwide leading positions in digital, cloud, data, advanced computing and security, it brings deep expertise for all industries in more than 53 countries. By uniting unique high-end technologies across the full digital continuum with 57,000 world-class talents, Eviden expands the possibilities of data and technology, now and for generations to come. Key Responsibilities Identify and assess clinical system data lineage and detect inconsistencies across systems. Evaluate data accuracy, completeness, and consistency across multiple data sources and platforms. Support root cause analysis and resolution of data quality issues within clinical data systems. Collaborate with clinical SMEs, engineers, and product teams to investigate data issues and develop remediation strategies. Develop and implement clinical data standards, element inventories, and frameworks to support governance and compliance across clinical programs. Guide cross-functional teams in clinical development and research settings on best practices and continuous improvement. Partner with internal stakeholders and external collaborators to ensure consistent data quality and alignment with regulatory expectations. Manage and coordinate activities with Contract Research Organizations (CROs), ensuring deliverables meet quality and compliance standards. Support integration efforts across clinical systems (eTMF, CTMS, EDC), ensuring seamless data flow through data transfer agreements and system interoperability. Stay current on evolving regulatory standards and apply best practices to safeguard clinical data integrity. Contribute to the development of strategic materials related to industry data quality and data governance initiatives. Required Qualifications and Skills Bachelor’s degree in Life Sciences, Clinical Research, or a related field with a minimum of 5 years of experience in clinical data management, clinical science, or a related domain. Excellent verbal and written communication skills, with strong interpersonal abilities. Demonstrated strong ability in data integration and harmonization across clinical systems and datasets. Expertise in quality checks specification development and quality control programming to ensure data accuracy and consistency. Understanding of industry standards for clinical data collection and regulatory submission. Strong analytical and problem-solving skills to identify and resolve data quality issues. Proficiency in system integration mapping and clinical system troubleshooting. In-depth knowledge of clinical trials, data mapping rules, regulatory guidelines, GCP, and data standards (e.g., MedDRA). Familiarity with life sciences standards such as ALCOA+, and relevant protocols and regulations. Experience developing processes, SOPs, and working instructions. Deep understanding of GCP (Good Clinical Practice) and GxP compliance. Familiarity with clinical systems and tools such as eTMF, CTMS, and EDC. Programming experience in SAS or SQL for data analysis and reporting a plus. Familiarity with ISO standards relevant to clinical data and quality systems a plus. Working knowledge of SDTM (Study Data Tabulation Model) standards and CDISC compliance a plus. Seniority level Mid-Senior level Employment type Full-time Job function Health Care Provider Industries Software Development #J-18808-Ljbffr Atos
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