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. Responsibilities include coordinating data management activities, providing input on project scope and timelines, and developing study documentation. You will also conduct user acceptance testing, data review, and query management, ensuring database lock and archival activities are completed. This role requires a college degree, minimum three years of industry experience in data management, and two years in a Data Manager role. 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 a minimum of three years of industry experience in Data Management
• Have two years in a 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
• Manage user access
• Review data
• Reconcile eCRF/External data
• Conduct medical coding (for staff with medical/Life Science background)
• Reconcile SAEs
• Manage queries
• Conduct Study Database Lock activities
• Archive CRFs
• Coordinate QC
• Report on project status
• Generate data listings/Patient profiles
• Maintain and QC TMF/eTMF as well as Data Management working files
• Train Data Managers and Assistant Data Manager
• Conduct project-specific training

Preferred Qualifications

Be willing to travel on an as needed basis for client presentations, bid defense meetings, department meetings, and the like