Immatics US, based in Houston, Texas, is a highly innovative biopharmaceutical company developing adoptive cellular immunotherapies against novel cancer targets. For additional information about Immatics, please visit our website www.immatics.com. We are currently seeking applicants for the following position:
Clinical Trial Data Manager
Immatics US is currently seeking a Clinical Trial Data Manager . The Clinical Trial Data Manager is responsible for the development, design, implementation and management of all clinical data systems and support data for statistical analysis to determine the efficiency of clinical trials and evaluate the results. Also responsible for collaborating with internal stakeholders to identify data reporting requirements and enhance the usage of clinical data.
Essential Job Functions
• Create case report forms (CRFs) and data management plans using Electronic Data Capture Management (EDC) database.
• Manage all phases of data management activities from study start and database close.
• Review and evaluate clinical patient data utilizing the electronic data system.
• Provide clarification of data and resolve queries related to CRFs.
• Manage and perform analyses on existing clinical databases to support regulatory submission or scientific publications.
• Work with clinical trial project teams and management to adhere to quality standards and project timelines.
• Assist in developing and revising data management and statistical operating procedures and working instructions.
• Assist in the project management of data management function of clinical research organizations (CROs).
• Possess and maintain a broad overall knowledge in the field of clinical programming and clinical data management by reading related literature, self-training, attending training classes, attending professional meetings, etc.
• Performs all other duties as assigned.
Minimum Required Education, Experience and Skills
• Bachelor’s Degree in science, chemistry or math.
• Minimum three years of data management experience in clinical trials in a pharmaceutical company or clinical research organization
• Data reporting and programming efficiency in SAS, SQL
• Familiarity with CTCAE, MedDRA, and/or WHO Drug Dictionary coding
• Ability to work independently and prioritize work for timely completion
• Able and willing to maintain strict level of confidentiality
• Strong analytical, problem-solving and organizational skills with a high level of comfort sourcing, manipulating and visualizing clinical data
• Familiarity with medical terminology and Good Clinical Practices
Preferred Education, Experience & Skills
• Advanced Degree in Data Management, Statistics or Science
• Familiarity with Medidata Rave, IBM Merge, Inform or DataTrack EDC system
• Oncology clinical trial data management and statistical analyses experience
• Knowledge of Microsoft Office to include Word, Excel, PowerPoint and Outlook
• Understanding of EDC architecture, output and data relationships
Please submit resume and cover letter to HR-US@immatics.com