Job Description

Senior Clinical Data Associate

Statistics & Data Corporation (SDC), A global contract research organization (CRO) headquartered in Arizona, providing clinical trial solutions for pharmaceutical, biologic, and medical device/diagnostic companies since 2005. Our core expertise is strategic scientific consulting and clinical data services which include biostatistics, data management/EDC, and IRT/IWRS.

Job Summary:
Performs clinical data management activities in support of clinical a research studies as a senior member of Data Review Center of Excellence, including review of clinical data, external vendor supplied clinical data, laboratory data, serious adverse event data, unexpected adverse device events, query management (identification, generation, resolution review and close-out).

Primary Responsibilities

• Track and maintain audit-ready clinical study documentation in support of data and listing reviews within the

electronic Trial Master Files for multiple projects

• Perform query management including data listing review, query creation and resolution on multiple studies as

needed to assist lead Clinical Data Managers

• Performs independent central data review in support of various risk-based monitoring solutions; reviews

reports, graphs, visualizations, quality tolerances, listings, key performance indicators to ensure cross site
excellence and risk mitigation.

• Mentor and train Clinical Data Associates in clinical data review and other CDA activities
• Assist and create study level metrics, as necessary
• Ability to work on multiple deliverables for different studies, as required
• Identity data issues and follow-up with relevant functional teams
• Perform/ Supervise 3rd Party Reconciliation Serious Adverse Event Reconciliation
• Adhere to all aspects of the SDC's quality system
• Comply with SDC's data integrity & business ethics requirements
• Perform other duties as assigned
• Adherence to all essential systems and processes that are required at SDC to maintain compliance to

business and regulatory requirements

• Able to perform all Clinical Data Associate job responsibilities with minimal supervision
• Take ownership of all study deliverables assigned to Data Review Center of Excellence.
• The above statements describe the general nature and level of work being performed by individuals assigned to

this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified

Requirements

Required Skills

• Working knowledge of clinical trials and data management's role in the clinical trials process
• Proficiency with Microsoft Word and Excel software and other MS office products
• Ability to work well independently and in a team environment
• Excellent organizational skills and attention to detail
• Ability to successfully work on multiple projects and prioritize daily tasks and responsibilities
• Effective communications skills both written and verbal
• Possess strong problem-solving skills, be solution-oriented
• Familiarity of regulatory guidelines (FDA/CFR, ICH/GCP)
• Additional skills include the following: familiarity with electronic data capture systems and/or clinical research coordinator role

Education or Equivalent Experience

• Bachelor's degree, preferably in applied or life science, with at least 3 years of experience in data management of clinical trials or equivalent education and work experience.