Clinical Data Manager
Company: Beacon Hill Staffing Group - Pharma
Posted on: October 11, 2018
Work in conjunction with external vendors, CRO(s), to Review/Create (electronic) Case Report Forms and annotated Case Report Forms per Protocol Review validation of database structure (DVS), data capture screens, code lists, edit checks, listings and other functions in EDC (e.g. User Acceptance Testing) Develop data transfer agreements and specifications with various vendors Review eCRF completion guidelines, data management plan (DMP), data validation specifications (DVS, e.g. edit checks), SAE Reconciliation Plan, Data Cleaning Plan and other DM related documentation in conjunction with CRO(s) Assist CRO(s) with cleaning data for Interim Analysis, Database lock, and any add hoc requests. Liaise with external vendors (Central Labs) in support of timelines and data related deliverables; may also liaise with clinical monitoring in the data management function Perform all aspects of Data Management as related to processing and QC of the data, monitor study status, (e.g. Enrollment, eCRFs, Query Aging, etc.) and provide status reports to the team throughout the study Responsible for working with database build vendor to develop new EDC databases and subsequent revisions. Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports and input from project team members. Review and approve study timelines Monitor timelines and ensure that clinical data management timeline are met with quality Use industry standard conventions, tools, references and process in support of the coding of Medical History, Adverse Events and ConMeds/ConProcs Ensures all DM procedures are executed with a high attention to detail, accuracy and timelines Review and provide feedback on Protocols, Statistical Analysis Plans and CSRs Represent DM on project teams, at Face-to-Face Meetings, Conferences, etc. Co-create and review DM SOPs and Work Instructions in accordance with current GCP and ICH guidelines Work in conjunction with internal and external Clinical Operations, Research, Clinical Data Management, Pharmacovigilence and other operational departments to ensure accurate, efficient, and complete data collection Ensure adherence to Data Management standards Ability to travel (travel time 10%, Global Travel) Other duties as assigned Computer Skills: Proficient in Microsoft Office applications (PowerPoint, Microsoft Word, Microsoft Excel, etc.), Internet software, E-mail Experience with Electronic Data Capture (EDC) systems Experience with reviewing SAS datasets Experience with CDISC SDTM/CDASH Qualifications B.S./B.A. in Science related field 5-8 years of Clinical Data Management experience in the pharmaceutical or biotechnology industry. Highly organized and detail-oriented with effective planning and strong verbal and written communication skills Flexibility and agility to adapt to changing scope of work, able to propose thoughtful solutions to challenges and issues, proactively implement solutions, and communicate effectively with colleagues Experience/knowledge of GCP and ICH guidelines
Keywords: Beacon Hill Staffing Group - Pharma, Irvine , Clinical Data Manager, Healthcare , Irvine, California
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