Clinical Data Senior Specialist

Role Overview

Clinical Data Senior Specialist at Khalifa University, College of Medicine and Health Sciences. The role manages and oversees end-to-end clinical research data management activities for assigned studies, from study start-up through database lock.

Role Purpose

Serve as the primary point of contact for all study-related data management functions, ensuring high-quality data delivery, effective quality control and assurance, regulatory compliance, and efficient study execution. Support the development of standard operating procedures, data collection tools, electronic databases, QC reports, and training initiatives for internal teams, faculty, and collaborators.

Key Responsibilities

Study Leadership & Oversight

• Lead assigned clinical research studies as the primary data management lead, including sponsor-facing responsibilities.
• Own data management deliverables for all assigned studies.
• Monitor and ensure timely data collection, coding, and cleaning in accordance with study timelines.
• Support GCP inspections and external audits, representing the data management function as needed.

Electronic Data Capture & Systems

• Lead and coordinate the design, development, testing, and deployment of EDC systems, ensuring timelines and quality standards are met.
• Develop and design eCRFs, edit checks, validation rules, branching logic, and contribute to rapid CRF generation post protocol finalization.
• Lead the design, development, testing, implementation, and administration of EDC systems, with a focus on REDCap.
• Serve as subject matter expert in REDCap programming and system configuration.
• Manage REDCap users, roles, and permissions in compliance with data security and governance requirements.
• Provide ongoing technical support to research teams.

Data Quality & Validation

• Perform regular data reviews, ongoing data cleaning, review, and quality checks.
• Lead discrepancy management and issue resolution in collaboration with internal teams.
• Establish and maintain data review plans and quality assurance protocols.

External Data Management

• Establish, track, and manage external data streams including central labs and imaging.
• Manage data transfer agreements with external partners.

Database Closure & Compliance

• Lead database lock and archival activities, ensuring documents are monitored and inspection ready.
• Lead database lock and archival processes.
• Ensure all data documentation is audit-ready.
• Support internal and external audits and GCP inspections.
• Ensure compliance with relevant ICH-GCP, 21 CFR Part 11, other regulatory, and sponsor-specific standards.

Documentation & Procedure Development

• Draft and maintain data management plans, CRF completion guidelines, edit check specifications, and SOP development.
• Support the development of standard operating procedures.

Training & Mentorship

• Develop and deliver REDCap training programs.
• Mentor junior staff and promote best practices in data management.

Information Security & Governance

• Ensure adherence to the University's information security policies and procedures.
• Report breaches or other security risks accordingly.
• Ensure coordination with other departments to facilitate the accomplishment of tasks and responsibilities, as and when needed.

General Responsibilities

• Demonstrate a strong commitment and practice to maintaining a safe and healthy work environment.
• Perform any other tasks assigned by Line Manager.

Qualifications & Experience

• Master's degree from a reputable university in life science, health science, computer science, or related discipline.
• Minimum 7 years of overall experience, with minimum 4 years of experience in clinical research data management.

Skills & Competencies

• REDCap programming and system configuration expertise.
• Electronic data capture system design, development, and administration.
• Data quality management and validation.
• Knowledge of ICH-GCP, 21 CFR Part 11, and other regulatory standards.
• Standard operating procedure development.
• Training program development and delivery.
• Audit preparation and management.
• Information security compliance.

Additional Information

• PhD from a reputable university in life science, health science, computer science, or related discipline is desired.