Senior Clinical Data Manager, Rave (Contract, Home-Based) - RSS

Essential Duties and Responsibilities:

Partner with Sr. Data Manager on all DM start-up activities in the RAVE system, including the development of CRFs/eCRFs/CRF specifications

Edit check specifications DVP and DEG Data Management Plan(DMP) and related Data Management Files(DMF)

Perform the testing of database systems. Includes initial user acceptance testing (UAT) of CRFs/Edit checks/data outputs and UAT of Change Orders throughout the course of a studyPerform data review and query management for EDC studies

Create ad hoc reports to assist with tracking and review of dataRun SAS reports to identify data issues  

Qualifications and Work Experience:

Minimum 2 years of experience in clinical data management within the drug or medical device industry

Proficiency using electronic clinical data management systems, specifically in Medidata Rave systems.

Medidata build certified candidate is a plus.

Experience of creating CRF/Edit specification in EDC system Experience of writing DVP (Data Validation Plan) and DEG (Data Entry Guides)

Experience of creating DMP (Data Management Plan)

Project management skill when working with vendors in EDC database build Knowledge of data reporting systems such as SAS

Knowledge of medical, clinical research, and data management process and terminology

Knowledge of  The Good Clinical Data Management Practices (GCDMP) and Food and Drug Administration (FDA) medical device regulations and guidelines

Strong written, verbal, analytical, interpersonal and time management skills, demonstrated capability of working on multiple projects at one time

Organized and detail-oriented

Team-based work experience preferred

Highly customer service oriented and excellent communication skills

Effective problem-solving skills as well as ability to proactively identifying process improvements which reduce operational costs and maintain quality

Education Requirement:

Four-year BA (or equivalent) degree in life science, computer science, or business management disciplines

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At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

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