Data Manager

📋 Description

• • Serve as the primary internal and Sponsor contact for all data-related questions, issues, and escalations concerning data collection, cleaning, delivery, reconciliation, timelines, and database lock in global clinical studies.
• • Define, maintain, and communicate the Data Management Plan (DMP) in close collaboration with Sponsors and internal Clinical Data Management teams to ensure alignment with study objectives and regulatory standards.
• • Determine, document, and implement standard and study-specific edit checks and data processing guidelines to ensure the highest quality and integrity of clinical trial data.
• • Collaborate with internal teams to define study setup requirements, including demographics collection protocols and visit schedule configurations for electronic data capture systems.
• • Lead the development, review, and finalization of data transfer requirements, including file specifications, formats, and sponsor approvals for all data exchanges.
• • Coordinate with SAS Programmers to support data file creation, edit check development, validation activities, and data quality assurance processes.
• • Generate and deliver sample, routine, complete, and final data transfers to Sponsors in strict accordance with study timelines and regulatory expectations.
• • Manage and oversee database lock activities, including sponsor coordination, query resolution, and final sign-off to ensure data integrity and timely study milestones.
• • Act as the primary point of contact for Data Correction Requests (DCRs), managing escalation paths, resolution tracking, and documentation throughout the data cleaning lifecycle.
• • Participate in the review and approval of Data Management components to ensure accurate and compliant study setups from initiation through closure.
• • Maintain complete, accurate, and up-to-date Data Management documentation including DMPs, file specifications, data transfer agreements, DCR logs, and all sponsor communication records.
• • Identify out-of-scope requests and formally escalate them to the Project Manager for Change Order processing to safeguard project scope and timeline integrity.
• • Conduct routine status meetings with Sponsors, CRO partners, and internal teams, including preparation of agendas, facilitation of discussions, and distribution of detailed meeting minutes.
• • Support monthly reporting activities by compiling and providing accurate Data Management metrics such as query resolution rates, data entry completeness, and timeline adherence.
• • Deliver high levels of customer satisfaction by consistently meeting sponsor commitments, quality benchmarks, and agreed-upon timelines across multiple concurrent clinical studies.
• • Ensure all data management practices comply with regulatory requirements and internal quality standards to support audit readiness and sponsor inspections.
• • Collaborate cross-functionally with Clinical Operations, Biostatistics, and Regulatory teams to align data workflows and ensure seamless data flow from source to analysis.
• • Proactively identify process inefficiencies and propose improvements to enhance data quality, reduce cycle times, and improve overall study performance.