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Clinical Data Manager (Bay Area, CA)The Clinical Data Manager will: Review protocols for proper data capture including Case Report Form design. Able to perform a thoroughly detailed review of CRF data requirements. Designs CRFs and creates annotated CRF and CRF completion guidelines. Develop a Data Management Plan that outlines CRF flow, data queries, manual checks, and data listings needed to facilitate Data Management activities throughout a clinical study. Leads and coordinates the design and testing of clinical study databases to match CRFs according to company standards. Able to resolve database issues with team members Supervise and assist with clinical data entry as needed Setup databases for individual study protocols Develop data edit check specifications and run data listings as required Generate data query forms to be resolved at investigational sites and enter resolutions into database Perform coding of adverse events, concomitant medications and medical history Import electronic data into the database Perform database lock and freeze activities per company SOPs Perform Serious Adverse Event reconciliation activities according to SOPs and guidelines Provides guidance and monitors the progress of data management activities with CROs or other vendors Ability to present clinical study CRFs and CRF completion instructions at investigator meetings and other trainings as needed. Participate in regular team meetings and provide input when appropriate Provide input into the development of data management SOPs and processes Interact with CRAs, programmers, study managers and statisticians in creating an clinical study database, performs data quality assurance activities, and manages the resolution of data queries Assist in database upgrades/migrations including performing User Acceptance Tests Ability to write or review Data Management work instructions and SOPs Ability to review and provide feedback to the clinical team on other study documents e.g. Clinical Monitoring plans, Statistical analysis plans and vendor specifications Ability to maintain study workbooks and data management files Contributes to a professional working environment including the application of Jazz Pharmaceuticals Code of Business Conduct and Ethics Assist with the training of new employees and/or contractors ESSENTIAL REQUIREMENTS: BA/BS or equivalent experience, preferably in the scientific/health care field. At least 5 years in Data Management for the pharmaceutical/biotechnology industry.. Experience with Relational databases, SQL, SAS and Clinical Data Management Systems. Understands the scope and focus of clinical trials phase 1-4 and has a proven ability to perform the tasks, manage vendor resources and timelines. Possesses an in-depth understanding of regulatory guidelines e.g. ICH, GCDMP, 21 CFR 11 and their application to Data Management practice. Knowledge of and experience with MedDRA, WHODrug and other Thesaurus classification or controlled terminology systems. Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors. Possesses strong English language written and verbal communication skills. Experience and understanding of the CNS therapeutic area is desirable. Experience with Phase III Pivotal studies is desirable. Able to travel to off-site meetings or training seminars as needed. Possesses solid computer system and technical skills with a strong ability to learn multiple e computer applications. Prior experience with different Data Management systems and technologies, Electronic Data Capture systems and CDISC data standards are desirable. Please submit resumes to jobs@jazzpharma.com This job ad has expired. Click here for active job ads. |
