Senior Clinical Data Manager

Target Pay Rate: 40-50/hr **salary will be commensurate with experience

Responsibilities

The Contract Senior Manager, Standards and Systems, Clinical Data Management will play a critical role in supporting the ongoing development and maintenance of the Global Library (GLIB) as it relates to the mapping and configuration of Rave Safety Gateway module within Medidata Rave. This position will focus on the design, programming, and implementation of complex custom functions and case report form (CRF) updates to enhance data management processes and ensure alignment with global standards. Key responsibilities and experience required for this role is as follows:

**Technical Expertise**

• **Medidata Rave Safety Gateway Module**: Hands-on experience configuring and maintaining Rave Safety integrations, including AE data flow to Safety systems (e.g., E2B format compatibility and data consistency checks).
• **RSG Workflow Knowledge**:
• In-depth understanding of RSG workflows, including mapping, setup, and management in Rave.
• Ability to define, monitor, and troubleshoot RSG logic across various study phases.
• **RSG Custom Function (C#) Programming**:
• Hands-on experience in writing, validating, and deploying Custom Functions for RSG workflows.
• Familiarity with dynamic RSG programming aligned with protocol-specific and safety requirements.
• **Global Library Development and Usage Knowledge**:
• Experience in developing and maintaining Global CRF Library (GLIB) assets, including form reuse, standard object implementation, and global edit checks.
• Ability to contribute to or manage updates to GLIB based on evolving standards.
• Develop and maintain Excel VBA tools for data validation and QC
• Perform cross-sheet and cross-workbook validation to identify inconsistencies, missing data, and formatting issues
• Validate RSG ALS files, including mappings, configurations, and data structures
• Implement QC checks based on business rules and standards
• Generate QC reports with clear, actionable findings
• Project Management responsibilities by owning and managing deliverables, timelines, and dependencies, coordinating across internal and external partners, tracking issues/risks and drive resolution, lead communications and provide status updates
• Strong Excel VBA programming experience (core requirement)
• Proven experience in data validation, QC, or reconciliation across complex Excel files
• Strong analytical skills and attention to detail
• Effective communication and stakeholder management
  
  

**Process and Standards Alignment**

• Consistently apply and enforce GLIB standards throughout the development lifecycle.
• Proactively identify issues and collaborate effectively with cross-functional teams (e.g., Data Management, Safety, Biostatistics, and DM Service Providers).
• Strong documentation and communication skills, including the ability to manage specifications, programming deliverables, and validation reports.