Principal Clinical Data Associate
Location: Deerfield, IL, USA (Remote)
Requisition Number: 595
Company Overview:
Advanced Clinical is a leading clinical development and strategic resourcing organization, dedicated to improving the clinical research experience. With decades of expertise, we empower our clients to achieve better outcomes by providing innovative solutions and fostering a culture of foresight, character, and resilience.
Position Overview:
The Principal Clinical Data Associate (CDA) plays a crucial role in overseeing and performing data management activities for clinical studies. This individual brings comprehensive expertise, exceeding the responsibilities of a Senior Clinical Data Associate, and serves as a key contributor to data integrity, consistency, and compliance throughout the clinical trial lifecycle.
Essential Functions:
1. Core Responsibilities:
Perform and oversee all data review activities for assigned clinical studies.
Provide oversight and mentoring to other CDAs.
Assist the Lead Data Manager with critical data management tasks.
Ensure data consistency, completeness, and quality through comprehensive manual data reviews and query management.
Identify and address data trends, inconsistencies, and quality issues, working collaboratively to implement corrective actions.
2. Study Start-Up Support:
Contribute to the creation of essential start-up documents, including the Data Management Plan (DMP), electronic Case Report Form Completion Guidelines (eCCGs), and Edit Check Specifications.
Perform user acceptance testing (UAT) and ensure system readiness.
Assist with electronic data capture (EDC) module setup and integrations (e.g., ePRO, Randomization, Dispensing).
3. Data Review and Management:
Conduct data listing and manual data reviews.
Generate and manage manual queries, ensuring timely resolution.
Reconcile Serious Adverse Events (SAEs) and external vendor data.
Review and respond to site queries, re-issuing queries when necessary.
Perform data entry or quality control (QC) reviews of local laboratory data.
Monitor study metrics and report findings.
Manage user accounts and perform EDC archival tasks.
4. Quality Assurance and Compliance:
Maintain a strong understanding of departmental and company Standard Operating Procedures (SOPs).
Guide and train other Clinical Data Associates on internal procedures.
Participate in the development and revision of SOPs to ensure continuous improvement and compliance with regulatory standards.
5. Business Development:
Support the business development process through activities such as Request for Information (RFI) completion, proposal development, and participation in bid defenses.
Represent the company at industry and scientific meetings.
6. Leadership and Mentoring:
Serve as a subject matter expert (SME) in clinical data management.
Provide training and mentorship to junior and senior Clinical Data Associates.
Participate in candidate interviews for data management roles.
7. Additional Responsibilities:
Perform other duties as requested by management.
Ensure active participation in cross-functional teams to address clinical data challenges proactively.
Qualifications:
Education:
Bachelor’s Degree preferred; equivalent work experience may be substituted.
Experience:
Minimum of 7 years of direct clinical data management experience in pharmaceutical development or within a Contract Research Organization (CRO) environment.
Working knowledge of CDASH (Clinical Data Acquisition Standards Harmonization) standards.
Technical Skills:
Proficiency in EDC systems and clinical data management platforms.
Strong analytical and problem-solving skills.
Excellent oral and written communication skills, with a keen attention to detail.
Soft Skills:
Ability to manage multiple priorities in a fast-paced environment.
Collaborative mindset, with a focus on building strong cross-functional relationships.
Commitment to continuous learning and professional development.
Why Join Advanced Clinical?
Opportunity to work in a dynamic and innovative environment that values foresight, character, and resilience.
Be part of a mission-driven team dedicated to improving the lives of those touched by clinical research.
Enjoy remote flexibility while contributing to cutting-edge drug development initiatives.
How to Apply:
Interested candidates can apply by submitting their resume and cover letter to the Advanced Clinical careers portal, referencing Requisition Number 595.
Advanced Clinical is an equal opportunity employer and welcomes applicants from diverse backgrounds.
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