Clinical Data Management (CDM)

Job Description

<p>Clinical Data Manager</p><p><br></p><p><br></p><p><br></p><p>Job Purpose/Summary: Serve as Clinical Data Management (CDM) represents CDM on Avicemer CRO project teams. Responsible for study specific CDM document development and maintenance. Responsible for project status reporting to Avicemer CRO project team, CDM management, and sponsors. Responsible for data cleaning process from start-up through data archival. Develop and/or approve project database builds, testing, and validation. Coordinate receipt and processing of information for projects as well as third party electronic data utilized on projects.</p><p><br></p><p><br></p><p><br></p><p>What You’ll Do</p><p><br></p><p>• Perform and/or direct activity of CDM team members to complete project deliverables on schedule according to quality standards, requirements, and project budget from study start-up through archival</p><p><br></p><p>• Develop and maintain study specific documents including: Case Report Forms, CRF Completion Guidelines, Clinical Data Management Plan, Annotated CRFs, and Edit Specifications</p><p><br></p><p>• Serve as Avicemer CDM representative on project teams</p><p><br></p><p>• 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</p><p><br></p><p>• Maintain open and effective communication with internal and external customers by contacting Sponsor counterparts 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</p><p><br></p><p>• 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</p><p><br></p><p>• Develop and continuously evaluate timelines in relation to work completed and communicate impact on milestones to CDM management, project team members, and Sponsor</p><p><br></p><p>• Maintain consistent, manageable workflow for CDM project team by monitoring enrollment information and communicating with project team to actively influence data collection</p><p><br></p><p>• Monitor quality of work performed by CDM project team and compliance with Avicemer SOPs and provide feedback to team</p><p><br></p><p>• Develop project reports which meet needs of sponsors, project team, and Avicemer CRO management, are accurate, and are provided to sponsor and CDM management upon request or per a predefined schedule</p><p><br></p><p>• Coordinate receipt and handling of data received from external sources (i.e., central laboratory, electrocardiogram [ECG], sponsor-coding dictionaries) and direct reconciliation where applicable</p><p><br></p><p>• 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</p><p><br></p><p>• Maintain current study specific documentation to accurately reflect process deviations and changes in project assumptions or scope of contracted work</p><p><br></p><p>• Database development and programming including functional testing</p><p><br></p><p>• Clinical data review</p><p><br></p><p>• Provide or arrange for adequate project specific training for CDM team and other study team members</p><p><br></p><p>• Maintain CDM project budget by identifying CDM activities outside scope of contracted work, obtaining agreement from sponsor or Avicemer CRO management prior to performing out-of-scope tasks</p><p><br></p><p>• Recommend alternative work processes to improve quality or speed of customer deliverables and respond to questions on CDM process, timelines, and data quality</p><p><br></p><p>What You Bring</p><p><br></p><p>• Msc or Postgraduate degree from an accredited university in clinical data management or Biostatistics is a MUST</p><p><br></p><p>• Excellent verbal and written communication skills</p><p><br></p><p>• Knowledge of regulatory guidelines</p><p><br></p><p>• Knowledge regarding medical terminology and drug nomenclature</p><p><br></p><p>• Knowledge of the drug development and clinical research process</p><p><br></p><p>• 1-2 years of related Clinical Data Management experience in either pharmaceutical or CRO environment</p><p><br></p><p>• Bachelor’s degree in life science and/or equivalent combination of education and clinical research experience</p><p><br></p><p>• Fluent in English</p>