Reportingto:Sr. Director, Clinical Data Management
This opportunity will ...
Provide strategic and operational leadership for clinical data management activities across one or more clinical development programs. The Associate Director will oversee CRO partners and vendors, drive data quality and inspection readiness, support regulatory submissions, and ensure the timely delivery of high-quality clinical trial data.
This role will serve as a key cross-functional leader, partnering with Clinical Operations, Biostatistics, Statistical Programming, Medical Writing, Pharmacovigilance, Regulatory Affairs, and external vendors to deliver study objectives while maintaining compliance with regulatory requirements and industry standards.
Accountabilities and Responsibilities:Clinical Data Management Leadership- 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 that support program timelines, quality objectives, and regulatory submission readiness.
- Ensure consistent application of Good Clinical Practice (GCP), ICH guidelines, company SOPs, and industry best practices.
- Provide leadership and guidance to CROs and vendors performing outsourced data management activities.
Vendor and CRO Oversight- Serve as the primary sponsor representative for outsourced data management activities.
- Establish governance and performance oversight processes, including KPIs, quality metrics, and issue escalation pathways.
- Review and approve vendor deliverables, including:
- Data Management Plans
- CRF specifications
- Edit Check Specifications
- Data Review Plans
- Database Validation Documentation
- Data Transfer Specifications
- Reconciliation Plans
- Monitor CRO performance and ensure accountability for quality, timelines, and budget adherence.
Data Quality and Inspection Readiness- Establish and monitor key study metrics related to data quality, data cleaning, query management, and database readiness.
- Lead ongoing review of data trends and identify risks requiring mitigation.
- Ensure audit and inspection readiness through comprehensive documentation and process compliance.
- Support internal audits and health authority inspections as the data management subject matter expert.
Cross-Functional Collaboration- 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.
Process Improvement- Identify opportunities to improve clinical data management processes, systems, and efficiencies.
- Contribute to the development and maintenance of SOPs, work instructions, templates, and best practices.
- Support implementation of innovative technologies and risk-based approaches to data management.
Requirements: Proven Experience, Skills, and Education:- 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.
Strong understanding of: - ICH-GCP
- FDA and EMA regulations
- CDISC standards (SDTM and related submission requirements)
- Clinical trial data lifecycle
- Risk-based quality management principles
This position is based in Boston, MA, and offers a flexible hybrid work model with a minimum of 2 days/week in the office.
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