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Job #02687

About our client Our client is a reputable, mid-size CRO that is experiencing unprecedented growth and is headquartered in Newton, MA. The company has an experienced management team, a robust pipeline and an empowering corporate culture that is focused o n the professional development of its employees. Position Location Senior Clinical Data Manager Newton, Massachusetts Salary Highly competitive package, commensurate with experience Responsibilities 1) Coordinate all Clinical Data Management tasks for a project, including the development of CRF completion guidelines, Data Management Plan (DMP) and other Clinical Data Management documents 2) Develop and implement project specific Clinical Data Management Systems and/or processes for assigned projects based upon the needs of the Project Management Team, clinical data management guidelines and client requests 3) Develop and implement plans for the processing of data within established timelines and budget specifications and make necessary adjustments based upon the project and the client’s needs 4) Design and develop study specific clinical databases and edit checks 5) Perform database testing and testing of edit check programs 6) Manage data entry processes for studies like developing data entry guidelines, training Data Entry staff on study specific processes and setting-up and making necessary modifications based on feedback 7) Review Case Report Forms for consistency and clarity as well as generating and resolving data queries 8) Provide analysis and feedback to the Director of Clinical Data Management and/or Project Team on Clinical Data Management tasks, systems or processes 9) Identify and communicate out of scope issues 10) Communicate with all departments (as necessary) regarding project status/issues 11) Enter and verify patient data into database system (as needed) 12) Perform auto-encoding procedures and/or quality control procedures 13) Oversee database quality control audit, document database audit finding and generate database audit error report 14) Oversee the set up and maintenance of Biometrics Central Files Requirements 1) Bachelor’s degree in a scientific discipline with 5+ years of industry experience, or equivalent 2) 5+ years of experience in Clinical Data Management 3) Experience with coding dictionaries (WHO, COSTART, ICD-9, MedDRA), ORACLE and EDC 4) Experience with database design and development 5) Experience in SAS a plus 6) Superb organizational and prioritization skills 7) Ability to handle multiple projects and work in a team environment 8) Proficiency in Microsoft Word, Access, Excel, PowerPoint and PageMaker 9) Excellent written and verbal communication skills