Preparing, validating and maintaining clinical trialdatabases according to ICH/GCP guidelines and current regulatory requirements. Developing and designing Case Report Forms, Case Report Form guidelines, data entry guidelines and related operations manuals/guidelines. Entering, verifying and reviewing clinical data. Developing data validation specifications and programs for assuring the accuracy of clinical trial data, e.g., manual data review guidelines, computerized edit check programs, Data Management Plans (DMP). Generating and managing clinical trial data queries. Coding specified clinical trial data, e.g. adverse events and concomitant medications. Reconciling serious adverse events. Tracking and reporting data management project status. Managing and controlling clinical data documents/files. Supporting project data collection training activities for CRAs and study site personnel. Leading data management activities for clinical trials where Alkermes is responsible for data management and database quality. Assisting in computer system development initiatives and database integration projects. Oversight of data management vendors and participation in outsourcing/vendor selection for Data Management services and software.
- Familiarity with industry standards or proprietary data management systems/software for managing and reporting clinical trials data.
- Knowledge of clinical research, medical terminology/disease processes and clinical practice.
- Technically astute with ability to understand programming logic concepts; current in areas of database preparation including database design, verification, processing, data transfer, data coding and database closing; document imaging; forms design.
- Familiarity with Windows environment, Office 2010 (including MS Access), Visual Basic, SAS, SQL and/or other clinical programming.
- Familiarity with application of clinical data coding classification systems, e.g., MedDRA, WHO-Drug.
- Ability to communicate well and represent data management effectively and diplomatically in a project team environment.
- Strong interpersonal, communication, organization, critical thinking, and problem-solving skills; able to adapt to internal/external deadlines and oversee vendors.
- BA/BS or equivalent in scientific discipline, nursing, health information management or computer-related field with a minimum 5 years experience in biopharmaceutical or CRO/medical/clinical data management environment.
- Demonstrated ability to work on multiple projects simultaneously. Demonstrated experience with Electronic Data Capture (EDC).