Data Manager, Laboratory Services

Cti Laboratory Data Management Representative

Serve as primary CTI Laboratory Data Management (LDM) contact with project team leadership, sponsors and/or CROs and represent LDM on CTI Labs project teams

What You'll Do

• Serve as CTI LDM representative on project teams
• Work with Laboratory Project Managers (LPM) and/or CRO/Sponsor Data Management in the setup of study-specific 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 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 Procedures (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
• Support the laboratory project manager in the maintenance of the LDM project budget by identifying LDM activities outside of 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 pre-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 basis

What You 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
• Ability to work independently and be self-motivated
• At least 4 years of related Laboratory Data Manager experience in either clinical research or central lab environment
• At least 2 years of relational database experience
• Bachelor's degree and/or equivalent combination of education and clinical research experience