This role will immediately assume study lead data management responsibilities for 3-5 concurrent respiratory and/or oncology clinical trials, utilizing primarily the Medidata RAVE electronic data capture and management system. The selected candidate will manage trials in various stages, from planning, to set-up, conduct, closeout, and archiving, in high volume, while maintaining a high level of data quality by leveraging and adhering to standard data structures and corresponding standard edit checks and review listings (within the EDC system and in SAS). The selected candidate may also manage and lead in the design and implementation of clinical data management processes with vendors, ensuring completeness, correctness, and consistency according to the Gilead standards. This role has a high degree of collaboration with the Clinical Operations team members, the EDC system staff, the Statistical Programming group, the Biostatistics group, the Biometrics Applications Development group, cross-functional study management team members, and other Clinical Data Associates. The ideal candidate will posses a BS degree in a Biomedical Science or equivalent and minimum 6 years of relevant experience along with clinical background/experience in Clinical Data Management in a CRO or bio/pharmaceutical setting. Previous work in oncology, respiratory, and/or inflammation clinical trials is highly desirable. Essential Duties and Job Functions: ? Works collaboratively with Clinical Programmers, Statistical Programmers, Biostatisticians, Clinical Research, DSPH, Regulatory and Project Management staff to meet project deliverables and timelines for moderately complex clinical data acquisition, quality checking and reporting. ? Ensures completeness, correctness and consistency of clinical data and data structure across all projects. ? Training and mentoring of CDM staff on business process and clinical programs. ? Participate in the development, review and implementation of processes, policies, SOPs and associated documents affecting CDM. ? Participate in CDM and cross functional initiative teams. ? Project level coordination of CDM tasks, while demonstrating knowledge of hands-on work. ? Communication and escalation of project level issues including processes, timelines, resourcing, performance, etc. ? Support of regulatory submission activities for assigned project. ? Assist with response to questions and findings from Clinical Quality Assurance (CQA) and other audits at the study / vendor level. ? Communicates with functional peers regarding project status and issues and ensure project team goals are met. ? Participates in the recruiting and hiring process for CDAs and support their professional development. ? Provides guidance and training to CROs, vendors, investigators, and study coordinators on study requirements. ? Excellent verbal and written communication skills and interpersonal skills are required. ? Working knowledge and experience with FDA regulations and familiarity with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA. Knowledge, Experience and Skills: ? 6 years of experience and a BS degree. ? 4 years of experience and a MS degree. ? 3 years of experience and a PhD.
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