About the role

The Sr. Clinical Research Manager is responsible for leading and executing the clinical data management strategy across multiple clinical studies, ensuring high-quality, compliant, and inspection‑ready data for regulatory submissions, or client use. This role requires operating at a high strategic level, driving data quality initiatives, optimizing processes, and elevating the data management function, while also providing strong people leadership to Clinical Data Managers and Clinical Data Specialists.

What you'll do

Strategic & Operational Leadership

• Drive the clinical data management vision, ensuring alignment with organizational goals, business needs, and regulatory/quality compliance.
• Assist in the development of Data Management Plans (DMPs), standards, templates, SOPs, and best practices.
• Lead continuous improvement initiatives to optimize workflows and enhance data quality and operations.
• Stay current on industry trends, regulatory updates, and emerging data technologies.
• Manage client and customer relationships to meet and exceed their expectations

People Management & Team Development

• Manage and mentor Clinical Data Managers and Clinical Data Specialists.
• Provide coaching, resource allocation, and performance development.
• Foster a collaborative, quality-driven team culture.
• Support team members in troubleshooting data workflows and quality processes.

Study Oversight & Execution

• Oversee all CDM activities from study start-up through database lock.
• Lead DC system requirements, UAT, and maintenance.
• Ensure compliance with FDA 21 CFR Part 11, ISO 14155, ICH-GCP, and CDISC standards.
• Oversee data cleaning, discrepancy management, and reconciliation across data sources.

Cross‑Functional Collaboration

• Serve as primary CDM contact for clinical, regulatory, quality, statistics, and software/EDC partners.
• Ensure seamless communication and timely issue resolution.
• Support the Data management, clinical operations, and quality org design and strategic planning as a member of the Clinical leadership team
• Support regulatory submissions through high-quality data documentation and audit readiness.

Qualifications

Education

• Bachelor’s or Master’s degree in Life Sciences, Clinical Research, Data Science, Health Informatics, or related field.
• CCDM certification preferred.

Experience

• 8+ years of clinical operations or data management experience.
• 2+ years of people management experience.
• Experience with EDC systems (RAVE, Veeva, InForm, Medrio, etc.).
• Strong ability to manage multiple studies and cross-functional priorities.

Skills & Competencies

• Strong leadership, communication, and mentoring abilities.
• Excellent analytical and problem‑solving skills.
• Ability to set strategic direction while managing operational details.
• Proficiency in data standards, EDC tools, and data review processes.
• Healthy disdain for the status quo

LOCATION AND TRAVEL REQUIREMENTS: This is a fully remote position and may be performed anywhere within the United States of America. Occasional domestic travel may be required for company meetings, audits, etc.

This employer participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.