Website:
acrosian.com
Job details:
About the Role
We are looking for an experienced Head of Clinical Data Management to lead and scale our global Clinical Data Management and Clinical Database Build organization.
This role owns end-to-end delivery across both functions, data management strategy, and data quality, as well as clinical database design, build, validation, and lock. You will lead a global team, partner directly with Pharma and Biotech sponsors, and set the operating standards that govern how we deliver.
You will also help shape how emerging technologies, including AI-enabled capabilities within our EDC, eSource, ePRO, and IRT platforms, are evaluated, validated, and adopted responsibly across our portfolio.
Key Responsibilities
Delivery & Operational Excellence
- Provide strategic and operational leadership for Clinical Data Management and Clinical Database Build across a global portfolio of studies.
- Drive end-to-end delivery excellence, on time, within budget, and to the highest quality standards.
- Own database build strategy: eCRF design standards, edit-check specifications, validation approach, UAT governance, and database lock activities.
- Develop departmental strategy, resource forecasting, capacity planning, and workforce plans to support current and future business needs.
- Monitor departmental KPIs, financial performance, utilization, quality metrics, and operational efficiency, driving continuous improvement.
People & Organization
- Lead and mentor Data Management Managers, Lead Data Managers, and functional leaders, fostering accountability, collaboration, and continuous improvement.
- Lead recruitment, succession planning, performance management, and talent development to build a high-performing organization.
Quality & Compliance
- Establish and continuously improve departmental SOPs, work instructions, templates, and best practices to ensure standardized, compliant processes.
- Drive inspection readiness and ensure compliance with ICH E6(R3), ICH-GCP, FDA 21 CFR Part 11, CDISC standards, and applicable regional regulatory requirements.
Technology & Innovation
- Partner with technology and quality functions to evaluate AI-enabled modules across EDC, eSource, ePRO, and IRT platforms, assessing fitness for purpose, validation burden, and sponsor acceptability.
- Oversee validation strategies, testing protocols, and quality assurance for new platform capabilities to ensure system readiness and regulatory compliance.
- Contribute to governance frameworks covering the controlled adoption, monitoring, and lifecycle management of AI-assisted capabilities in regulated clinical workflows.
Client & Business Development
- Build strong sponsor partnerships through governance meetings, executive reviews, and serving as the senior escalation point for delivery and operational issues.
- Support Business Development through RFIs, RFPs, proposal development, capability presentations, and bid defense meetings.
Qualifications
Required
- Degree in Life Sciences, Pharmacy, Biotechnology, Computer Science, or a related discipline.
- 15+ years of progressive experience in Clinical Data Management within a CRO, pharmaceutical, or biotechnology environment.
- Proven leadership experience managing global Data Management teams across multiple concurrent programs.
- Strong expertise in clinical database build, data management delivery, database lock, and risk-based data management approaches.
- Hands-on experience with industry-leading EDC platforms.
- Experience supporting business development activities, including RFP responses and bid defense meetings.
- Working knowledge of computerized system validation and 21 CFR Part 11 / Annex 11 requirements.
- Excellent communication, stakeholder management, conflict resolution, negotiation, and executive presentation skills.
What We're Looking For
- A strategic thinker with a hands-on leadership approach.
- A strong people leader with a track record of building and developing high-performing teams.
- Someone who can prioritize competing business needs, manage risk proactively, and drive execution in a fast-paced environment.
- A genuine customer focus and the ability to build trusted, long-term sponsor relationships.
- Passion for operational excellence, innovation, and continuous improvement.
If you're passionate about leading global Clinical Data Management teams and shaping how clinical research gets delivered, we'd love to hear from you.
If interested, please apply at careers@acrosian.com.
Click on Apply to know more.
