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Sr. Clinical Data Associate (Seattle, WA)DEPARTMENT: Clinical Development (SEATTLE, WASHINGTON) DATE: March, 2007 REPORTS TO: Director, Biostatistics PURPOSE: Under the general direction of the Director, Biostatistics, the Sr. Clinical Data Associate will be responsible for: Company data management operations (including both in house data management operations and oversight of data management Clinical Research Organization (CROs) in support of OncoGenex clinical studies. RELATIONSHIPS AND ESSENTIAL RESPONSIBILITIES: The Sr. Clinical Data Associate will be responsible for: Data management tasks as necessary for in-house data management system including data entry and verification, edit check generation and processing, database audit, and database lock. When data management responsibilities are outsourced to a contract research organization: o Assist the Director, Biostatistics to identify an appropriately qualified vendor. o After vendor selection, work closely with project managers and data managers from the CRO to ensure accuracy, completeness and timeliness of data processing. Ensure that data management activities are in compliance with study time lines, ICH GCP guidelines, internal SOPs and meet all regulatory requirements. Working in conjunction with the clinical development team on case report form design, data collection processes, query generation procedures, project timelines. Write study-specific data management plan and ensure data management activities described therein are implemented. Works closely with the Director, Biostatistics during the conduct of the trial. Performs other tasks and projects as assigned. QUALIFICATIONS: BA/BS in life sciences (e.g. biology) or technical discipline (e.g. computer science). A minimum of five years of relevant data management experience in biotechnology or the pharmaceutical industry, including experience in oncology and in various phases of drug development. SKILLS: Knowledge of medical terminology an asset. Direct experience performing clinical data management (CDM) activities associated with study start-up, maintenance and closeout. Energetic, results-oriented. Dedication to quality and reliability in all work tasks. Must have strong communication skills, including verbal and written. Must be detail oriented with strong organizational skills, the ability to prioritize and work efficiently on multiple tasks. Ability to work independently and in a team environment. Excellent organizational skills with proven project planning ability. Computer Skills: Experienced in Microsoft Office suite of products and able to transfer data between applications (e.g. Excel to SAS). Ability to travel as necessary, consistent with project needs. CONTACTS: Required to interact with CROs and others external to the Company. This job ad has expired. Click here for active job ads. |
