RESPONSIBILITIES: 1. Develop and maintain project-specific Data Management plan throughout the life-cycle of the study protocol, which includes case report form (CRF) annotation, database specifications, data dictionary, edit checks and other pertinent data management documents; maintain documentation in accordance with regulatory requirements. 2. Develop CRF specifications according to protocol and approved standards (based on industry standards). 3. Develop protocol-specific edit check specifications. 4. Report status and provide updates of Clinical Data Management activities to project teams and management. 5. Perform entry of clinical trial data when the DataFax system is used. 6. Establish database locking procedures; perform data cleaning and reconciliation. 7. Review and provide feedback on Adverse Event coding, MedDRA updates and subscriptions in collaboration with Safety Adverse Event (SAE) desk. 8. Perform iDataFax validation and create/conduct data simulation in preparation for study initiation. 9. Train clinical trial sites on completion of CRFs and entering study data into iDataFax. QUALIFICATIONS: 1. Bachelor's degree with > 10 years of experience or Master's degree in computer science, health profession, or related field and at least 3 years of clinical data management experience, or Ph.D. in a HIV research-related field. 2. Clinical data management experience required with Phase 1 & 2 studies, or Phase 2 & 3 studies. The successful candidate will also have experience performing data management responsibilities for multiple studies, including managing more than one study concurrently. 3. Required Knowledge and Expertise. The successful candidate must demonstrate knowledge, expertise and proficiency in the data management field, and have experience in: - Data management gained through clinical drug trials in large pharmaceutical/biopharmaceutical companies, or in a CRO, including non-profit organizations with a drug development core. - Knowledge of and experience in developing CRFs or e-CRFs. - Experience in developing a data management plan. - Experience training clinical sites to enter clinical data, and managing the data transfer. - Experience with query resolution and data reconciliation. - Thorough understanding of clinical data management methodology. - Experience with standard coding dictionaries (i.e. MedDRA and WHODRUG). - Knowledge of and experience with clinical database design (either in Rave or SAS) and remote data entry technology. - Working knowledge of applicable federal regulations. - Strong oral and written communication skills. Additional Experience - Knowledge of SAS programming is a plus. - Knowledge of DataFax a plus. 4. The successful candidate must be detail-oriented, a self-starter, takes the initiative, and produce high-quality deliverables. 5. Must be able to work independently on assigned projects and effectively meet deadlines, adhere to project timelines milestone. 6. Must be an effective and productive Clinical team member, and work cooperatively with the team.
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