Clinical Data Analyst I

We work with focus, agility, and shared purpose - moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry leading innovation, With Heart.

About the Role

We are seeking a Clinical Data Analyst (Data Manager, Clinical Operations Analyst) to join our team in a hybrid / on-site capacity. As a Clinical Data Analyst, you will support clinical research activities that advance new treatments for patients. This position plays a key role in study execution, data integrity oversight, regulatory compliance, and clinical data accuracy. You'll collaborate with cross-functional teams, follow industry-standard processes, and contribute to study operations from planning through database lock.

Responsibilities include managing clinical data review workflows, resolving data discrepancies, and ensuring data quality through systematic query management and vendor reconciliation. With diverse teams and continuous learning opportunities, the Clinical Data Analyst can explore career paths and expand skills across clinical data management, regulatory affairs, and clinical operations.

Key Responsibilities

• Conduct comprehensive clinical data reviews and data cleaning activities to ensure accuracy, completeness, and compliance with study protocols and regulatory requirements

• Review clinical data listings and identify discrepancies, inconsistencies, and data quality issues requiring resolution

• Manage query workflows, including query generation, tracking, resolution, and documentation to support timely database closure

• Perform vendor data reconciliation activities, including local laboratory data review and external data verification to ensure data integrity

• Execute CRF freeze and lock activities in accordance with study timelines and regulatory standards, coordinating with clinical sites and internal teams

• Conduct User Acceptance Testing (UAT) for data listings, system screens, and edit checks to validate system functionality and data accuracy

• Maintain comprehensive study documentation within Veeva Vault and eTMF systems, ensuring proper organization, version control, and regulatory compliance

• Collaborate with cross-functional stakeholders including clinical monitors, programmers, biostatisticians, and regulatory teams to resolve data issues and support study milestones

• Demonstrate proficiency with clinical data workbench tools and EDC systems to support efficient data management and analysis

You'll thrive in this role if you bring:

• Strong expertise in clinical data review, data cleaning, and query management processes

• Hands-on experience with EDC systems and clinical data analysis tools in a fast-paced environment

• Proficiency with Veeva Vault, eTMF documentation systems, and clinical data workbench platforms

• Experience working in clinical research, healthcare, or a regulated environment with attention to regulatory compliance

• The ability to collaborate across teams and communicate clearly with internal and external stakeholders

• A patient-focused mindset and exceptional attention to detail in managing complex clinical datasets

• Comfort working with multiple software systems and a commitment to continuous learning

Required Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Clinical Research, or a related scientific discipline

• Minimum 2+ years of experience in Clinical Data Management within a CRO, pharmaceutical, or biotechnology environment

• Hands-on experience with EDC systems, preferably Medidata RAVE and Oracle Clinical

• Working knowledge of clinical research regulations, GCP guidelines, and clinical trial processes

• Knowledge of ICH-GCP, regulatory requirements, and 21 CFR Part 11 compliance

• Strong communication, organization, and problem-solving skills

Preferred Qualifications

• Experience with data review tools such as J-Review or Spotfire

• Proficiency with Microsoft Project and advanced PowerPoint presentations

• Experience in vendor reconciliation and database lock activities

• Familiarity with clinical trial data management best practices and quality assurance processes