Clinical Data Senior Specialist

Job description

Clinical Research Data Senior Specialist is responsible to manage and oversee end-to-end clinical 
research data management activities for assigned studies within the College of Medicine and Health 
Sciences, from study start-up through database lock.

The role serves as the primary point of contact for all study-related data management functions, 
including the design, implementation, validation, and maintenance of electronic data capture systems, particularly REDCap.  

The position is also responsible for ensuring high-quality data delivery, effective quality control and 
assurance, regulatory compliance, and efficient study execution, while supporting the development of 
standard operating procedures, data collection tools, electronic databases, QC reports, and training 
initiatives for internal teams, faculty, and collaborators. 

Required Qualifications

Masters from a reputable university in a life science, health science, computer science or related discipline

Desired Criteria

PhD from a reputable university in a life science, health science, computer science or related discipline

Required Experience

A minimum 7 years of experience with minimum of 4 years of experience in clinical research data management

Operational Responsibilities

Serve as the primary data management lead for assigned clinical research studies, including sponsor- facing responsibilities and ownership of data management deliverables Lead and co-ordinate the design, development, testing and deployment of EDC systems, ensuring timelines and quality standards are met.

Develop and design eCRFS and 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. 

Develop and deliver REDCap training programs.

Provide ongoing technical support to research teams.

Mentor junior staff and promote best practices in data management.

Draft and maintain data management plans, CRF completion guidelines, edit check specifications and data review plans and SOP development.

Establish, track and manage external data streams (e.g. central labs, imaging etc) including data transfer agreements.

Perform regular data reviews, ongoing data cleaning, review, and quality checks, discrepancy management and issue resolution in collaboration with internal teams.

Lead database lock and archival activities, ensuring documents are monitored and inspection ready.

Monitor and ensure timely data collection, coding and cleaning in accordance to study timelines.

Support GCP inspections and external audits, representing the data management function as needed.

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.

Ensure adherence to the University's information security policies and procedures, and report breaches or other security risks accordingly.

Ensure coordination with other departments to facilitate the accomplishment of tasks and responsibilities, as and when needed.

Demonstrate a strong commitment and practice to maintaining a safe and healthy work environment.

Perform any other tasks assigned by Line Manager.