Position Summary:
The Senior Manager, Clinical Data Engineering manages the day-to-day activities of the Clinical Data Engineering function in accordance with Standard Operating Procedures (SOPs), regulatory directives, and study specific plans with an emphasis on effective resourcing and development of personnel. Provides oversight for data engineering projects; coordinates inter-departmental and client communication and helps resolve administrative, personnel, and project issues. The Senior Manager, Clinical Data Engineering is responsible for cross functional standardization and harmonization, technology and process improvement and resource and business forecasting. Collaborates with executive management on the ongoing development of the Clinical Data Engineering function and facilitates certain initiatives/special projects such as department level training, software and/or systems analysis or implementation.
Essential functions of the job include but are not limited to:
Strategic Data Architecture Governance:
Define and implement scalable clinical data architecture frameworks that support global trial execution. Lead enterprise-wide initiatives for data standardization, harmonization, and regulatory compliance (e.g., GCP, FDA 21 CFR Part 11). Establish governance protocols for metadata, audit trails, and documentation to ensure inspection readiness.
Data Engineering Leadership:
Oversee the design and deployment of intelligent data mapping strategies across therapeutic areas. Architect and maintain modular, reusable codebases using Python, R, SQL, and SAS to support clinical data pipelines. Set technical standards for programming, validation, and automation across the data engineering team.
Quality Assurance Validation Systems:
Develop and manage adaptive validation systems that proactively identify and resolve systemic data issues. Lead root-cause analysis and continuous improvement efforts in collaboration with data management and clinical operations. Ensure robust data integrity through automated checks, reconciliation workflows, and exception handling.
Cross-Functional Collaboration:
Serve as a strategic partner to Biostatistics, Clinical Operations, Regulatory Affairs, and IT to align data engineering efforts with broader clinical goals. Provide technical guidance and mentorship to junior engineers and cross-functional stakeholders. Act as a senior advisor on emerging technologies, including AI/ML tools, cloud platforms, and data visualization systems.
Infrastructure Automation:
Evaluate and implement automation solutions to streamline workflows and reduce manual effort.
Regulatory Compliance Oversight:
Ensure all systems and processes align with global regulatory standards and internal SOPs. Lead documentation efforts for audit readiness, including traceability matrices, validation plans, and system specifications.
Innovation Continuous Improvement:
Drive adoption of cutting-edge technologies to enhance data workflows and analytics capabilities. Monitor industry trends and regulatory changes to inform strategic planning and system upgrades. Champion a culture of innovation, accountability, and operational excellence within the data engineering function.
Team Capacity Resource Allocation
- Lead resource planning and allocation across multiple concurrent clinical data engineering initiatives. Monitor team bandwidth and adjust assignments to optimize productivity and ensure timely delivery of critical milestones. Partner with Clinical Science and Centralized Monitoring leadership to forecast staffing needs and support strategic hiring decisions.
Book of Work Oversight:
Maintain a comprehensive book-of-work covering all active and planned data engineering projects. Ensure alignment of workstreams with organizational priorities, clinical development timelines, and regulatory deliverables. Track progress against key performance indicators (KPIs) and escalate risks or delays proactively.
Qualifications:
Minimum Required:
- Bachelor s Degree in a relevant field (life sciences, statistics, data management, clinical operations) or relevant/equivalent combination of education, training, and experience
- 8 years or more experience in clinical data engineering, programming, or data management in either a CRO/or pharmaceutical or biotech industry or equivalent relevant experience and or demonstrated competencies
- Experience managing programming or data engineering teams
Other Required:
- Highly effective oral and written communication skills with the ability to communicate effectively with project team members
- Excellent organizational and time management skills
- Ability to work in a team or independently as required
- Proficiency in statistical analysis and data monitoring tools.
- Detail-oriented with strong analytical and problem-solving skills
- Demonstrated experience with integrated risk planning management
- Ability to mentor junior team members
Preferred:
- CRO experience as a clinical data engineering or programming line manager
Skills:
- Strong analytical and problem-solving skills with attention to data quality and integrity.
- Effective communication skills to collaborate with cross-functional teams.
- Knowledge of data governance, privacy, and security best practices in clinical research.
Competencies
- Collaboration: Works effectively with clinical, statistical, and technical teams to align data strategies with study goals.
- Coaching and Development: Support direct reports with goal setting, continuous improvement and career progression
- Innovation: Continuously seeks opportunities to improve data workflows and implement automation.
- Accountability: Takes ownership of data engineering deliverables and ensures timely, high-quality outputs.
- Adaptability: Thrives in a fast-paced, evolving environment with shifting priorities and timelines.
- Compliance-Oriented: Maintains a strong focus on regulatory compliance and data traceability.
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