Senior Data Manager, Laboratory Services

What You'll Do  

• Direct activity of LDM team members to complete project deliverables on schedule according to quality standards, requirements, and project budget from project start-up through archival
• Trains and mentors members of the LDM team in the setup and maintenance of studies using laboratory information management system (LIMS) software 
• Provides guidance and review for new programs writing by the LDM group
• Serve as CTI LDM representative on project teams
• Work with Laboratory Project Managers and/ or CRO/Sponsor Data Management in the setup of study-specific database at commencement of new projects, and with any midstream project changes; perform database quality control checks before database activations
• Perform or facilitate database cleaning procedures in conjunction with project team and sites over the course of assigned projects to ensure a clean database lock period
• Collaborate with clients to develop data transfer agreements
• Plan and orchestrate interim and end-of-project data transfers with project sponsor and internal teams
• Recommend best practices to improve quality or speed of customer deliverables and respond to questions on LDM process, timelines, and data quality
• Maintain positive working relationship with internal customers and sponsor by keeping them up-to-date about progress of projects and working with them to develop coordinated plans that meet customers’ needs
• Maintain open communication with internal and external customers by contacting sponsor counterpart on agreed-upon schedule, responding to correspondence promptly and within agreed upon timeframes and choosing method of communication based on urgency and type of information being communicated
• Evaluate team requests by considering factors such as efficiency, quality, budget, resources, and customer relations before committing to an action; seek out existing knowledge prior to developing new methods                                       
• Develop and maintain LDM study files; identify all internal and sponsor LDM deliverables contracted in scope of work and establish time estimates; specify data cleaning guidelines, conventions, Global Standard Operating Procedure (GSOP), data workflow, and other processes, which will be followed to meet sponsor requirements                        
• Continuously evaluate timelines in relation to work completed and communicate impact on milestones to laboratory leadership, project team members, and sponsor
• Monitor quality of work performed by LDM project team and compliance with GSOPs and provide feedback to team                                                 
• Support the laboratory project manager in the maintenance of the LDM project budget by identifying LDM activities outside scope of contracted work, obtaining agreement from sponsor or CTI management prior to performing out-of-scope tasks, preparing or reviewing budget and cost analysis documentation routinely, and following scope issues through to resolution                                                       
• Provide or arrange for adequate project specific training for LDM team members           
• Develop project reports which meet needs of sponsors, project team, and CTI laboratory leadership, are accurate, and are provided to sponsor and LDM management upon request or a re-arranged schedule     
• Coordinate receipt and handling of data received from external sources (e.g., contracted laboratories) and direct reconciliation where applicable
• Prepare in advance for internal and external meetings, complete action items within required timeframe, and attend internal meetings regularly, providing input, and demonstrating respect for opinions of others                                               
• Conduct post-mortem analysis after study completion to determine positive and negative factors affecting the project and provide information along with study metrics to laboratory leadership                                                                              
• Provide effective and timely feedback to management for performance reviews of project team members on an ongoing basi

 

What You'll Bring

• Excellent verbal and written communication skills
• Knowledge of regulatory guidelines
• Knowledge regarding medical terminology and drug nomenclature
• Knowledge of the drug development and clinical research process
• Excellent written and oral communication skills
• Ability to work independently and be self-motivated
• At least 5 years of related Laboratory Data Management experience in either clinical research or central lab environment
• At least 4 years of relational database experience
• Bachelor’s degree and/or equivalent c