Lead Data Manager

Summary

Join our team as a Lead Data Manager and oversee all data management activities in assigned clinical trials. You will be the primary communication point for project teams, company departments, and clients/vendors regarding clinical data management aspects. Responsibilities include coordinating data management activities, providing input on project scope and budget, and developing study documentation. You will also conduct user acceptance testing, data review, query management, and database lock activities. This role requires a minimum of three years of industry experience in data management, including two years as a Data Manager. Travel is required.

Requirements

• Have a College or University degree or equivalent combination of training and experience that presents the required knowledge, skills, and abilities
• Have minimum of three years of industry experience in Data Management
• Have two years in Data Manager role

Responsibilities

• Be responsible for all data management activities in assigned clinical trials under supervision
• Act as primary communication point for project teams and company departments regarding clinical data management
• Act as primary communication point for clients/vendors for all data management aspects of clinical projects
• Coordinate data management activities within clinical projects related to EDC development, data collection, cleaning, reconciliation, Database Lock, development of final integrated database and generation of final Data Management deliverables
• Provide input into monitoring of project scope, budget, timelines, and deliverables
• Be responsible for clinical data management activities including, but not limited to: Development of study documentation (eCRF Requirements, Edit Checks Specification, Data Management Plan, CRF Completion Guidelines, User Access Management Plan, Data Validation Plan, External Data Transfer Agreements, SAE Reconciliation Guidelines, Local Lab Normal Ranges Guidelines, Coding Guidelines where applicable)
• Conduct user acceptance testing
• Conduct user access management
• Conduct data review
• Conduct eCRF/External data reconciliation
• Conduct medical coding (for staff with medical/Life Science background)
• Conduct SAE reconciliation
• Conduct query management
• Conduct Study Database Lock activities
• Conduct Archival of CRFs QC Coordination
• Conduct Project status reporting
• Conduct Data listings/Patient profiles generation
• Maintain and QC TMF/eTMF as well as Data Management working files
• Train Data Managers and Assistant Data Manager
• Conduct project-specific training