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Title:Clinical Data Coordinator II
Salary:Open
Experience:2+
Location:CA - South San Francisco

Description:
The Clinical Data Coordinator II has primary responsibility for data management over one or more clinical trials, and may also serve as the data manager for a project, providing guidance to Junior Data Managers.

Responsibilities:

·         Maintain a project-level perspective on data management issues, activities and deliverables (i.e., reviewing protocols for cross-project consistency, identifying project-level standard Case Report Form (CRF or eCRF) modules, coordinating data management activities across protocols to meet overall project deadlines and objectives)

·         Manage projects resourced externally via contract research organizations or corporate partners

·         Train and mentor junior staff

·         Participate in departmental discussion groups, formal working groups or special projects

·         Develop data management documentation according to departmental SOPs

·         Provide early strategic input into protocol design focused on data management issues

·         Lead the development of eCRFs or paper CRFs by interacting with other functional area representatives

·         Coordinate the development, testing, and documentation of the operational database

·         Participate in user acceptance testing of the operational database and data checking procedures

·         Monitor receipt of data

·         Review and resolve data discrepancies generated by the system and issue manual queries as appropriate

·         Interact with Clinical Data Management specialty groups to ensure that project objectives are understood and met

·         Develop and execute ad hoc database queries or reports using standard reporting software (e.g., Integrated Review)

·         Monitor work performed by CRO or other vendors

·         Perform related tasks as needed

Requirements:

·         Ability to multi-task and effectively set own priorities

·         Good leadership skills

·         Ability to work well with others

·         Good problem solving skills

·         Knowledge of basic software applications (electronic mail, electronic calendar, MS windows, general file server use)

·         Knowledge of core clinical data management applications (UNIX, MS Word, web browser, relational database, query tools)

·         Clinical data management system experience (EDC preferred)

·         Accuracy and attention to detail

·         Understanding of the role of data management, biostatistics and statistical programming in the drug development process

·         Understanding of the conceptual basis for data management conventions, standards and processes

·         Good organizational skills

·         Good communication skills

·         Basic presentation skills

·         BA/BS

·         2 - 4 years of relevant experience

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