Clinical Data Associate

Clinical Data Manager

Primarily responsible for the business, operational, and compliance aspects of drug discovery, development, and marketed products. Clinical data managers work collaboratively with internal and external colleagues and vendors to support Gileads business objectives by ensuring the accurate and timely acquisition of diverse clinical data through efficient CRF/eCRF design, edit specifications, and query resolution processes.

Project Involvement

• May lead a study or group of related small studies.
• Demonstrates the ability to lead a study (ies)/project(s) with minimal supervision.
• Serves as a point of contact for study management team.
• Effectively interact with cross-functional team

Key Differentiating Contributions

• Assists in implementing routine activities involving CDM interaction with other study management team members.
• Reviews study protocols and assists site coordinators, investigators, and field clinical staff in collecting routine data to meet the protocol requirements in a timely manner.
• Identifies, tracks, and resolves routine queries and issues.
• The point of contact for Clinical Research regarding data management issues.
• Demonstrates ability to identify problems early and communicate escalation issues appropriately.

Job Responsibilities

• Works collaboratively with Programming (Clinical and Statistical), Clinical Operations, Biostatistics and others such as Clinical Research, DSPH, Regulatory and Project Management staff to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting.
• Demonstrates a general understanding of each assigned protocol, critical tasks and milestones.
• Ensure completeness, accuracy and consistency of routine clinical data and data structure.
• Assists in the implementation of routine clinical data management process with vendors including data entry, data quality checking, data transfer and reporting.
• May lead in the preparation of CRF/eCRF design.
• Reviews study protocol and assists site coordinators, investigators, and field clinical staff in collecting routine data to meet the protocol requirements in a timely manner. Identifies, tracks, and resolves routine queries.
• Utilizes routine reports to track study progress and ensures timeliness and quality expectations are met.
• Excellent verbal and written communication skills and interpersonal skills are required.
• The ability to problem solves and have people/project leadership skills.
• Knowledge of FDA/EMA regulations, support of needs for NDA and other regulatory submissions, and familiarity with web-based Electronic Data Capture (EDC) and clinical data management systems.
• Demonstrates understanding of project timelines and metrics to ensure databases are delivered to set timelines.

Typical Education & Experience

• 3 years of experience and a BS degree.