Head of Clinical Data Management (Pharma)
Мэтч & Сопровод
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Описание вакансии
TL;DR
Head of Clinical Data Management (Pharma): Overseeing all aspects of clinical data management across the development portfolio with an accent on strategic leadership, quality, and regulatory compliance. Focus on modernizing data capabilities through automation, AI-enabled workflows, and scalable GxP processes.
Location: Fully remote (Global)
Salary: $255,000 - $347,500 Annual
Company
Global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases.
What you will do
- Define and execute the strategic direction for Clinical Data Management across studies, programs, and evidence generation activities.
- Oversee CRF/eCRF design, database build and validation, data review, cleaning, and submission readiness.
- Build and lead a high-performing Data Management organization, including resource planning and talent development.
- Establish quality control and risk mitigation frameworks to ensure compliance with GCP and global regulatory requirements.
- Drive modernization initiatives including AI-enabled workflows, metadata-driven processes, and data interoperability.
- Partner with Biostatistics, Programming, and IT teams to advance integrated data and analytics ecosystems.
Requirements
- Master’s degree or PhD in Life Sciences, Computer Science, Data Science, Statistics, or a related discipline.
- 12+ years of progressive experience in Clinical Data Management within the pharmaceutical or biotechnology industry.
- 8+ years of leadership experience managing teams and complex development portfolios.
- Expertise in Phase 2 and Phase 3 global clinical trials and support for regulatory submissions (NDA/BLA/MAA/PMDA).
- Deep understanding of CDISC standards, EDC systems, and validated GxP environments.
- Strong experience with vendor oversight and global CRO partnerships.
Nice to have
- Experience in rare disease, respiratory, immunology, gene therapy, or specialty biotech development programs.
Culture & Benefits
- Fully remote work arrangement with occasional domestic and international travel (approx. 10%).
- Comprehensive medical, dental, and vision coverage, including mental health support (U.S. offerings).
- 401(k) plan with competitive company match and annual equity awards.
- Access to Company Learning Institute, LinkedIn Learning, and leadership programs.
- Generous paid time off, fertility and family-forming benefits, and flexible work schedules.
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