Assoc. Dir, Clinical Data Mgmt AI & Automation

Job Description

Leads and executes  clinical database development  and programming activities across multiple clinical programs. Ensures delivery of high-quality, compliant, and timely clinical database solutions aligned with established standards and study requirements.

Acts as a technical SME supporting study teams, cross-functional partners, and vendors. Contributes to database design, development, validation, and integration activities, while driving continuous improvement, operational efficiency, and consistency across Clinical Data processes.

Key Responsibilities:

Clinical Database Delivery & Execution (40%)

• Oversees and coordinates clinical database activities across multiple clinical programs

• Interfaces with CDS leadership to ensure consistency of technical strategies and execution

• Plans and manages timelines to ensure on-time delivery of database-related activities

• Collaborates with study teams, stakeholders, and vendors to translate requirements into deliverables

Database Development & Programming (20%)

• Designs, develops, and maintains clinical databases and data transfer files according to specifications

• Programs and validates edit checks, derivations, and scripts supporting data ingestion and integration

• Leads and participates in review of eCRFs, edit checks, and database build activities

• Ensures adherence to standards, SOPs, and process guidelines

Training, Mentorship & SME Support (20%)

• Trains new hires and supports ongoing capability development across the team

• Acts as a subject matter expert for troubleshooting, issue resolution, and best practices

• Promotes a high-quality, customer-focused, and collaborative working environment

Innovation, Process Improvement & Digital Enablement (15%)

• Leads and participates in task forces, system evaluations, and CDS technical initiatives

• Contributes innovative solutions to enhance processes and increase productivity

• Supports the evaluation and adoption of improved ways of working, including appropriate use of automation and data-driven approaches

• Demonstrates awareness of emerging digital capabilities (e.g., automation, advanced analytics, AI-enabled tools) and explores their applicability to improve efficiency and consistency

Planning & Coordination (5%)

• Supports project planning, resource forecasting, and workload distribution across therapy areas

• Aligns with CDS leadership to ensure consistency of approach across programs

Qualifications, Skills & Experience

• Bachelor’s degree in computer science, mathematics, science, or a related field (or equivalent experience)

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Experience

• 7-10 years of clinical database development and/or data programming experience

• Strong experience with clinical data management systems (e.g., Inform, Architect, Central Designer)

• Experience with Oracle databases and SQL/PL-SQL

• Experience working in regulated clinical development environments

Technical & Functional Skills

• Strong understanding of clinical database design, eCRFs, edit checks, and data validation

• Experience in programming data logic, integration workflows, and data transfer processes

• Knowledge of clinical data standards, regulatory requirements, and GxP/ICH guidelines

• Familiarity with end-to-end clinical data lifecycle and data cleaning processes

• Exposure to tools and approaches supporting automation, data workflows, and process optimization

Digital & Innovation Capabilities

• Demonstrated awareness of emerging digital capabilities, including automation and AI, and their potential application within clinical data management

• Ability to identify opportunities to improve processes using data-driven and automation approaches, while ensuring compliance within regulated environments

Core Skills

• Strong problem-solving and analytical thinking skills

• Effective communication and ability to present technical concepts clearly

• Strong collaboration and stakeholder engagement skills

• Ability to work independently and manage multiple priorities

• Strong attention to detail and commitment to quality and compliance

• Willingness to learn and adopt new processes and technologies

Required Skills:

Adaptability, Adaptability, Automation, Clinical Database Programming, Clinical Databases, Clinical Data Management, Clinical Development, Clinical Informatics, Clinical Trials, Data Analysis, Data Cleansing, Data Extraction, Data Integration, Data Validation, Decision Making, Good Clinical Practice (GCP), Interpersonal Relationships, Operational Efficiency, Oracle Database, People Leadership, Pharmacovigilance, PL/SQL (Programming Language), Project Planning, Proven Commitment, Regulatory Compliance {+ 2 more}

Required Skills:

Adaptability, Adaptability, Clinical Database Programming, Clinical Databases, Clinical Data Management, Clinical Data Standards, Clinical Development, Clinical Informatics, Computer Science, Data Analysis, Data Integration, Data Quality Assurance, Data Reporting, Data Validation, Detail-Oriented, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP), Interpersonal Relationships, Mentoring Staff, Mentorship, Operational Efficiency, Oracle Database, Project Management Tools, Project Planning, Regulatory Compliance {+ 1 more}

Preferred Skills:

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Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

07/15/2026

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