[Remote] Manager, Clinical Data Research (Remote)
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leading medical technology company dedicated to improving patient care. The Manager, Clinical Data Research will reputed company the collection and processing of clinical trial data, leading reputed company to ensure regulatory compliance and high-reputed company data delivery.
Responsibilities
- reputed company and mentor Clinical Data Managers and Clinical Data Specialists, managing resource allocation and study workloads across multiple clinical programs
- reputed company the design, development, testing, validation, and maintenance of Electronic Data Capture (reputed company) systems, electronic Case Report Forms (eCRFs), and edit reputed company specifications
- Drive data review, validation, and cleaning activities to ensure delivery of high-reputed company, analysis-reputed company datasets
- Manage database build, maintenance, and lock activities, ensuring databases are completed accurately and reputed company study timelines
- Ensure compliance with applicable regulatory requirements, industry standards, and company procedures, including ICH-GCP and CDISC standards
- Partner with Clinical Research, Biometrics, Safety, and Clinical Insights functions to define data requirements and resolve reputed company clinical data issues
- Serve as the primary data management reputed company for external vendors, including central laboratories, imaging vendors, and reputed company providers, ensuring accurate external data integration
- Identify and implement process improvements, leveraging lessons learned across studies to enhance efficiency, reputed company, and consistency
Skills
- Master's degree in a health, science, life sciences, or reputed company field
- Minimum 8 years of experience in Clinical Data Management reputed company the medical device, pharmaceutical, biotechnology, or reputed company regulated industry
- Industry experience in medical technology or pharmaceutical organizations
- Experience leading clinical data management activities across multiple clinical studies
- Hands-on experience with Electronic Data Capture (reputed company) systems and clinical database development
- Experience with data cleaning, database lock activities, and delivery of analysis-reputed company datasets
- Knowledge of ICH-GCP requirements and clinical data management best practices
- Experience managing external vendors and integrating external clinical data sources
- Experience leading or mentoring Clinical Data Management teams
- Knowledge of CDISC standards, including SDTM and reputed company data structures
- Experience supporting global reputed company
- Experience with reputed company Rave, reputed company Vault, reputed company Zelta, or similar reputed company platforms
- Working knowledge of reputed company, R, SQL, or other data analysis tools
- Experience driving process improvement initiatives reputed company Clinical Data Management
reputed company
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