Clinical Data Coordinator II

Clinical Data Coordinator II needed for a 6-month contract. Job description is as follows:Job 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) modules, coordinating data management activities across protocols to meet overall project deadlines and objectives)Manage projects resourced externally via contract research organizations or corporate partnersTrain and mentor junior staffParticipate in departmental discussion groups, formal working groups or special projectsDevelop Data Quality (DQ) Plans (specification of the data quality checks that will be performed by Clinical Data Management)Create, modify and test validation and derivation procedures to support implementation of DQ PlansProvide early strategic input into protocol design focused on data management issuesLead the development of CRFs by interacting with other functional area representatives and managing the physical development of CRFs through Forms DesignDevelop Data Management Plans (setting up primary database structures, data entry screens, etc.)Monitor CRF receipt and data entry progressCoordinate data entry, answering questions from data entry operatorsReview and resolve data discrepancies via standardized data validation systems and procedures and close interaction with project clinical research associatesPerform database updates as necessaryInteract regularly with Clinical Data Management specialty groups (Data Entry/Forms Design, Data Standards, Safety DataManagement, Data Quality Services) to ensure that project objectives are understood and metDevelop and execute ad hoc database queries using relational database toolsPerform related tasks as neededMinimum Requirements:
BA/BS
2 - 4 years of relevant experience
Clinical data management system experience (Oracle Clinical preferred)
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)
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
3-5 years data management experience.
CRO oversight experience.Smith Hanley Consulting Group,a division of Smith Hanley, specializes in providing clinical trials staffing to national pharmaceutical companies offering long-term contract services of Statisticians, SAS Programmers, Data Managers, Clinical Research Associates and other clinical specialties. Our professional recruiters are recognized leaders in the industry by placing junior to senior candidates into rewarding positions within leading pharmaceutical companies throughout the United States. For more than twenty years, we have built extensive client relationships. We strive to help our candidates make decisions that are consistent with their professional values, priorities and goals as well as provide our clients with candidates that meet their employment needs. www.shcgpharm.com


REQUIREMENTS
Pharm Group