Senior Manager, Clinical Data Management

Our client is a clinical-stage biotechnology company advancing a diverse pipeline of innovative therapies across multiple therapeutic areas. As the organization continues to expand its clinical development portfolio, they are seeking an experienced Senior Manager, Clinical Data Management to lead and oversee clinical data management activities supporting global clinical trials.

This individual will be responsible for ensuring the quality, integrity, and accessibility of clinical trial data across multiple electronic and external data sources while partnering closely with Clinical Operations, Biometrics, Statistical Programming, Clinical Development, Safety, and Regulatory Affairs.

The ideal candidate will bring strong technical expertise, vendor management experience, and a passion for building efficient, high-quality data management processes within a collaborative biotechnology environment.

Key Responsibilities

Clinical Data Management Leadership

• Lead and oversee clinical data management activities across multiple clinical development programs.
• Develop and optimize data flow strategies across EDC and non-EDC data sources.
• Ensure high-quality, accurate, complete, and inspection-ready clinical databases.
• Support the implementation and maintenance of CDISC-compliant data standards.

Vendor & CRO Oversight

• Manage Data Management CROs and external vendors responsible for database build, data cleaning, reconciliation, and study deliverables.
• Monitor vendor performance to ensure quality, timelines, and regulatory compliance.
• Build collaborative partnerships while maintaining accountability for project execution.

Clinical Database Management

• Review study protocols and collaborate on CRF design to ensure data collection aligns with study objectives.
• Oversee database development, testing, validation, and maintenance activities.
• Review clinical data for completeness, accuracy, consistency, and protocol compliance.
• Monitor data review metrics and identify opportunities for continuous process improvement.

Data Quality & Compliance

• Ensure compliance with CDISC standards and applicable regulatory requirements.
• Oversee SAE reconciliation and external vendor data reconciliation activities.
• Support database lock activities and readiness for statistical analyses.
• Provide accurate and timely clinical data to internal and external stakeholders.

Cross-Functional Collaboration

• Partner closely with Clinical Operations, Biostatistics, Statistical Programming, Medical Monitoring, Pharmacovigilance, Regulatory Affairs, and Clinical Development.
• Provide subject matter expertise throughout the clinical trial lifecycle.
• Support inspection readiness activities, audits, and regulatory inspections.
• Contribute to the development and maintenance of SOPs, work instructions, templates, and data management best practices.

Qualifications

Required

• Bachelor's degree in Life Sciences, Computer Science, Mathematics, Statistics, or related discipline.
• 5+ years of clinical data management experience within biotechnology, pharmaceutical, medical device, or CRO environments.
• Strong understanding of clinical trial data management processes from study startup through database lock.
• Experience managing external Data Management CROs and vendors.
• Working knowledge of CDISC standards including SDTM.
• Experience with industry-standard EDC systems such as Medidata Rave, Medrio, or similar platforms.
• Strong understanding of ICH-GCP, GCDMP, 21 CFR Part 11, and applicable regulatory guidelines.
• Excellent organizational, communication, and project management skills.
• Demonstrated ability to manage multiple studies in a fast-paced clinical development environment.

Preferred

• Experience supporting oncology, rare disease, immunology, autoimmune, or other complex therapeutic area clinical trials.
• Experience managing biomarker, imaging, laboratory, or other external clinical data.
• Familiarity with relational databases, SAS, SQL, or other clinical data tools.
• Experience with data visualization platforms such as Tableau, Power BI, R Shiny, or similar technologies.
• Experience contributing to inspection readiness and regulatory submissions.
• Previous experience working within an emerging or mid-sized biotechnology company.