Job Description

Principal Clinical Data Manager

Location: Onsite – San Diego, CA

Employment Type: Full-time

Job Description:

We are seeking an experienced Principal Clinical Data Manager to lead data management activities for our Phase III obesity clinical trials. This role requires extensive CRO oversight to ensure data integrity, compliance, and timely database lock. The ideal candidate will have a strong background in managing large-scale clinical trials and collaborating with cross-functional teams in a fast-paced environment.

Key Responsibilities:

• Oversee and manage all aspects of clinical data management (CDM) for Phase III obesity studies, ensuring compliance with regulatory requirements and industry best practices.
• Provide CRO oversight, including reviewing data management plans, monitoring deliverables, and ensuring high-quality data outputs.
• Serve as the primary point of contact between internal teams and external vendors for all CDM activities.
• Develop and implement data review strategies, ensuring accuracy, consistency, and completeness of clinical trial data.
• Lead database design, validation, and UAT activities to ensure robust and efficient data capture systems.
• Manage and track key CDM milestones, ensuring adherence to project timelines.
• Perform or oversee data cleaning, reconciliation, and query management in collaboration with internal and external stakeholders.
• Ensure compliance with GCP, ICH guidelines, FDA, and other regulatory requirements.
• Support regulatory submissions and inspection readiness efforts.
• Provide mentorship and leadership to junior data management staff.

Qualifications & Experience:

• Bachelor’s or Master’s degree in Life Sciences, Data Science, or a related field.
• 8+ years of clinical data management experience in a pharmaceutical, biotech, or CRO setting.
• Strong CRO oversight experience with a proven ability to manage vendor relationships effectively.
• Expertise in Phase III clinical trials, preferably in obesity or metabolic disorders.
• Proficiency in EDC systems (e.g., Medidata Rave, Veeva EDC) and data management tools.
• Solid understanding of CDISC standards (SDTM, ADaM) and regulatory data submission requirements.
• Excellent project management, communication, and problem-solving skills.
• Ability to work fully onsite in San Diego, CA.

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