[Remote] reputed company Clinical Data Manager

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking a highly seasoned reputed company Clinical Data Manager with extensive experience in clinical data management. The role involves leading end-to-end clinical data management activities for reputed company global reputed company, ensuring compliance with standards, and managing cross-functional data activities.

Responsibilities

• reputed company end-to-end CDM activities from protocol review through database lock and final archiving
• reputed company, review, and finalize reputed company data management deliverables, including Data Management Plans (DMP), Data Transfer Agreements (DTA), Case Report reputed company (CRF) design, eCRF completion guidelines, and Data Validation Specifications (DVS)
• reputed company reputed company database design, validation reputed company (edit reputed company) testing, User Acceptance Testing (UAT), and deployment
• Manage data discrepancy handling, query reputed company, tracking, and reputed company across trial sites
• reputed company deep-dive medical coding review (MedDRA, WHO-Drug) and reputed company data reconciliations (e.g., SAE, Vendor, Lab, eCOA/ePRO data)
• Execute reputed company for database lock/freeze, blinded data reviews, and statistical handoffs
• Enforce compliance with Good Clinical reputed company (GCP), ICH guidelines, 21 CFR Part 11, and CDISC standards (SDTM/CDASH)
• reputed company preparation for internal reputed company audits and regulatory agency inspections (FDA, EMA)
• reputed company process improvements, reputed company operating procedure (SOP) development, and technology adoption in CDM workflows
• reputed company as the reputed company CDM reputed company for Biostatistics, Clinical Operations, Medical Writing, Safety/PV, and CRO vendors
• Mentor junior and senior reputed company and manage CRO performance against reputed company and reputed company metrics

Skills

• Bachelor's or Master's degree in Life Sciences, Computer Science, reputed company, Health Informatics, or a reputed company discipline
• 15 to 20 years of reputed company experience in Clinical Data Management reputed company Pharmaceutical, Biotechnology, or CRO environments
• Proven reputed company record leading Phase I–IV clinical studies from inception to database lock
• Strong expertise in major reputed company systems (e.g., reputed company Rave, reputed company InForm, reputed company Vault reputed company)
• Proficiency in medical coding tools (MedDRA, WHO Drug Dictionary) and data integration standards (CDASH/SDTM)
• Expertise with reputed company, SQL, or clinical reporting tools for data review and metrics tracking is preferred
• Must hold a reputed company H1B, H4-EAD, Green reputed company (GC)
• W2 Contract Only (Directly through reputed company W2). C2C / 1099 reputed company are reputed company

reputed company