Beschreibung

In this role, you will be at the forefront of clinical data management, coordinating activities across projects, supervising data management tasks, and ensuring compliance during audits. Your expertise will guide the team and enhance data integrity while supporting business development efforts.

Anforderungen

• •College or University degree or equivalent training and experience
• •Minimum of five years of CRO industry experience as a Lead Data Manager or equivalent position
• •At least 3 years of experience using CDM/EDC systems (Medidata Rave or Oracle Inform preferable)
• •Project data management experience
• •Full working proficiency in English
• •Organizational and managerial skills

Aufgaben

• •Act as the primary communication point for project teams and departments regarding clinical data management
• •Serve as the main contact for clients and vendors on all data management aspects of clinical projects
• •Supervise all project data management activities for assigned studies
• •Coordinate data management activities within clinical projects, including EDC development and data collection
• •Oversee data cleaning, reconciliation, and database lock activities
• •Develop the final integrated database and generate final data management deliverables
• •Monitor project scope, budget, timelines, and deliverables
• •Manage clinical data management activities, including study documentation development and user acceptance testing
• •Handle user access management and data review processes
• •Reconcile eCRF and external data, and manage SAE reconciliation
• •Oversee query management and study database lock activities
• •Coordinate archival of CRFs and QC processes
• •Report project status and generate data listings and patient profiles
• •Maintain and QC the electronic trial master file (eTMF)
• •Maintain and QC data management working files
• •Prepare for and attend internal and client audits of data management
• •Follow up on and resolve audit findings related to data management
• •Train lead data managers, data managers, and assistant data managers
• •Conduct project-specific training for the clinical team on CRF completion
• •Present at investigator meetings
• •Provide input into proposals and assist with business development activities
• •Participate in process improvement activities at the corporate and departmental level