Associate Director, Data Management
X4 Pharmaceuticals
August 20, 2026
Remote friendly (Boston, MA)
United States
$175,000 - $200,000 USD yearly
Clinical Research and Development
Responsibilities:
- Lead and oversee all clinical data management activities for assigned clinical trials from protocol development through database lock and study closeout.
- Develop and execute data management strategies supporting 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.
- Serve as primary sponsor representative for outsourced data management; establish governance and performance oversight (KPIs, quality metrics, issue escalation).
- Review and approve vendor deliverables (Data Management Plans, CRF specifications, Edit Check Specifications, Data Review Plans, Database Validation Documentation, Data Transfer Specifications, Reconciliation Plans).
- Monitor CRO performance for quality, timelines, and budget adherence.
- Establish and monitor key study metrics for data quality, cleaning, query management, and database readiness; lead review of data trends and risk mitigation.
- Ensure audit and inspection readiness; support internal audits and health authority inspections as data management SME.
- Collaborate cross-functionally (Clinical Operations, Biostatistics, Statistical Programming, Medical Writing, Pharmacovigilance, Regulatory Affairs).
- Identify process improvement opportunities; contribute to SOPs/templates; support risk-based approaches and innovative technologies.
Requirements:
- 8+ years clinical data management experience in biotech/pharma/CRO.
- 3+ years leadership overseeing clinical data management and vendor relationships.
- Experience supporting Phase 2/3 and regulatory submission programs.
- Experience overseeing outsourced clinical data management models.
- Strategic thinker with strong operational execution; excellent vendor management.
- Problem-solving and risk management; excellent written/verbal communication.
- Commitment to patient-focused drug development and data quality excellence.
- Rare disease experience preferred.
Strong understanding of:
- ICH-GCP; FDA/EMA regulations; CDISC (SDTM); clinical trial data lifecycle; risk-based quality management.
Location/Work model:
- Boston, MA; flexible hybrid work model (minimum 2 days/week in office).
- Lead and oversee all clinical data management activities for assigned clinical trials from protocol development through database lock and study closeout.
- Develop and execute data management strategies supporting 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.
- Serve as primary sponsor representative for outsourced data management; establish governance and performance oversight (KPIs, quality metrics, issue escalation).
- Review and approve vendor deliverables (Data Management Plans, CRF specifications, Edit Check Specifications, Data Review Plans, Database Validation Documentation, Data Transfer Specifications, Reconciliation Plans).
- Monitor CRO performance for quality, timelines, and budget adherence.
- Establish and monitor key study metrics for data quality, cleaning, query management, and database readiness; lead review of data trends and risk mitigation.
- Ensure audit and inspection readiness; support internal audits and health authority inspections as data management SME.
- Collaborate cross-functionally (Clinical Operations, Biostatistics, Statistical Programming, Medical Writing, Pharmacovigilance, Regulatory Affairs).
- Identify process improvement opportunities; contribute to SOPs/templates; support risk-based approaches and innovative technologies.
Requirements:
- 8+ years clinical data management experience in biotech/pharma/CRO.
- 3+ years leadership overseeing clinical data management and vendor relationships.
- Experience supporting Phase 2/3 and regulatory submission programs.
- Experience overseeing outsourced clinical data management models.
- Strategic thinker with strong operational execution; excellent vendor management.
- Problem-solving and risk management; excellent written/verbal communication.
- Commitment to patient-focused drug development and data quality excellence.
- Rare disease experience preferred.
Strong understanding of:
- ICH-GCP; FDA/EMA regulations; CDISC (SDTM); clinical trial data lifecycle; risk-based quality management.
Location/Work model:
- Boston, MA; flexible hybrid work model (minimum 2 days/week in office).