Senior Clinical Data Specialist, Rave (Contract, Office-Based) - RSS (R1094462) in Rochelle Park, NJ at IQVIA™

Date Posted: 10/31/2019

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Job Description

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

Essential Duties and Responsibilities:

Partner with Sr. Data Manager on all DM start-up activities, including the development of

CRFs/eCRFs/CRF specifications

Edit check specifications

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 study Perform data review and query management for EDC studies Create ad hoc reports to assist with tracking and review of data Run 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, Medidata Rave system is preferred.

Medidata build certified candidate is a plus.

Experience of creating CRF/Edit specification in EDC system

Experience of creating DMP 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

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at to arrange for such an accommodation.

Job ID: R1094462