Manages the design, maintenance and locking of clinical trial databases. Acts as the data management team lead on all clinical study data issues when activities are outsourced, between Dynavax and a contract research organization, or other vendors
Responsible for approval of data management plans, EditCheck Plans, database definition documents, and data entry guidelines and conventions.
Responsible for study data acquisition and tracking of data received.
Ensures quality databases, including reviewing data to ensure quality and makes recommendations as needed.
Uses the appropriate software to coordinate completion of various duties, including data transfers and quality reviews of the database, database lock and release, archival of data management documentation and files, and coordination of coding for the adverse event and medication dictionaries.
Participates in review of clinical protocols and amendments and uses knowledge of protocol to coordinate the design and testing ofdata capture systemsMay lead review teams to review data quality reports. Generates, resolves, and tracks data queries to ensure the integrity of the clinical data with respect to data guidelines and protocol specifications. Identifies and resolves data management issues, in coordination with other departments.
Develops and produces reports using various software packages to assist in data management and maintenance. Detects data or other deficiencies and recommends corrective action, if needed.
Reports regularly to the project team on database status, available resources, and the ability to manage and meet timelines. Determines and initiates required follow-up and/or additional analysis.
Provides input in the development and implementation of Standard Operating Procedures and guidelines regarding clinical data management. Identifies enhancements or modifications to established data management practices and policies
Performs all responsibilities in accordance with company guidelines and Standard Operating Procedures and appropriate industry and regulatory standards and Good Clinical Practices.
Supports the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.
Other duties as assigned.
Bachelor/Master’s degree or equivalent with at least 5+ years of progressive experience in clinical data management, preferably in a pharmaceutical or biotechnology setting.
Advanced knowledge of Data Management processes and systems, including Electronic Data Capture (EDC).
Knowledge of Food and Drug Administration (FDA) and International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines is required.
Experience with all phases of clinical development; Phase III experience and experience in oncology trials is highly preferred.
Solid understanding of clinical drug development process is preferred.
Excellent organizational skills, problem solving skills and demonstrated ability to prioritize, multi-task and effectively manage multiple projects.
Proven ability to establish collaborative working relationships in a team environment.
Proficient computer skills, MS Office; Word, Excel, PowerPoint, and Outlook
Must willing and able to travel – approximately 5%.
Personal attributes including: integrity, flexibility, and action and goal oriented