Associate Director, Clinical Data Management – Rare Diseases

X4 Pharmaceuticals; Boston (MA); Hybrid; USD 160,000 - 210,000; Full time

Job summary

X4 Pharmaceuticals is seeking an Associate Director of Clinical Data Management in Boston. You will lead data management activities across programs, manage CRO/vendor relationships, and drive data quality and inspection readiness to support regulatory submissions.

The role collaborates with Clinical Operations, Biostatistics, Medical Writing, Pharmacovigilance, and Regulatory Affairs, ensuring compliant data delivery and study success in a hybrid work model.

Qualifications

• Minimum 8+ years of clinical data management experience within biotechnology, pharmaceutical, or CRO environments.
• Minimum 3+ years of leadership experience overseeing clinical data management activities and vendor relationships.
• Experience supporting Phase 2, Phase 3, and regulatory submission programs.
• Experience overseeing outsourced clinical data management models.
• Strategic thinker with strong operational execution skills.
• Excellent vendor management capabilities.
• Effective problem-solving and risk management abilities.
• Excellent written and verbal communication skills.
• Commitment to patient-focused drug development and data quality excellence.
• Rare disease experience preferred.

Responsibilities

• Lead and oversee all clinical data management activities for assigned trials from protocol development through database lock.
• Develop and execute data management strategies that support program timelines, quality objectives, and regulatory submission readiness.
• Ensure consistent application of GCP, ICH guidelines, company SOPs, and industry best practices.
• Provide leadership and guidance to CROs and vendors performing outsourced data management activities.
• Serve as the Data Management representative on Clinical Study Teams and Development Teams.
• Effectively communicate study status, risks, mitigation plans, and performance metrics to leadership.
• Foster strong collaborative relationships with internal teams and external partners.
• Identify opportunities to improve clinical data management processes, systems, and efficiencies.

Skills

Leadership

Vendor management

Data quality

Regulatory submissions

Clinical data management

Job description

X4 Pharmaceuticals is seeking an Associate Director of Clinical Data Management in Boston. You will lead data management activities across programs, manage CRO/vendor relationships, and drive data quality and inspection readiness to support regulatory submissions.

The role collaborates with Clinical Operations, Biostatistics, Medical Writing, Pharmacovigilance, and Regulatory Affairs, ensuring compliant data delivery and study success in a hybrid work model.