Clinical Data Management Programmer III

Job Summary

Join a dynamic and growing clinical research organisation at the forefront of data-driven innovation in clinical trials. We are committed to delivering high-quality, reliable data solutions that accelerate drug development and improve patient outcomes worldwide. Our collaborative, fast-paced environment empowers talented professionals to make a meaningful impact while continuously developing their skills.

This is an exciting opportunity for a detail-oriented and technically strong CDM professional to expand their expertise, contribute to process improvements, and work with industry-leading tools in a highly collaborative environment.

Responsibilities

Technical Programming - Study Delivery

• Lead and support technical and programming activities for allocated Clinical Data Management projects.
• Review programming requirements and timelines in collaboration with the Manager - CDM Programming and the Lead CDM.
• Ensure programming deliverables are completed to agreed timelines and quality standards.
• Support programming activities required for study reporting and data deliverables.
• Be aware of and work to the standards appropriate to the study.

Quality, Compliance Governance

• Perform code reviews to ensure programming quality, consistency, and compliance with company standards.
• Conduct internal audits and reviews of study documentation, programming outputs, and processes to ensure compliance with Quanticate standards.
• Perform quality control checks on programming outputs and maintain quality tracking documentation.
• Ensure work is conducted in accordance with study-specific requirements, applicable SOPs, GCP, and regulatory expectations.
• Support system upgrades, implementation activities, and change control processes.
• Assist with programming tasks for reporting of allocated projects, as required.
• Perform quality control checks on programming outputs.

Leadership, Process Improvement - Operational Support

• Lead and mentor junior programmers, providing guidance, training, and issue resolution support.
• Drive continuous improvement activities in collaboration with the Manager - CDM Programming.
• Initiate and implement process improvement ideas and provide recommendations for enhancements to procedures and standards.
• Manage user administration activities, including user access management, user access reviews, and e-learning assignments.
• Work with the Manager - CDM Programming on process improvement tasks.
• Initiate and implement process improvement ideas.
• Provide opinions and recommendations on possible improvements to procedures and standards.

Clinical Database Development - Configuration

• Annotate the master CRF.
• Assist with the definition of clinical databases and the setup and testing of data entry screens.
• Set up electronic consistency checks where required.
• Assist with the writing and testing of edit checks.

Data Integration Processing

• Set up imports of electronic data as required.
• Assist with the setup of systems used for study processing.
• Prepare electronic data exports and associated documentation for study completion and data transfer activities.
• Perform User Management activities, including user access management, user access reviews, and e-learning assignments.

Project Coordination & Communication

• Report progress against project schedules to the Project Data Manager or Lead Clinical Data Manager.
• Communicate effectively with internal and external customers regarding project activities and deliverables.
• Perform other reasonable tasks as requested by management.

Knowledge

• Knowledge of industry-standard systems such as SDTM, CDISC, and CDASH.
• Knowledge of EDC systems and clinical database technologies, including Medidata Rave and Medrio.
• Understanding of Clinical Data Management processes.
• Thorough knowledge of ICH Guidelines, Good Clinical Practice (GCP), and applicable regulatory requirements.

Work Experience

• 4+ years of experience in the pharmaceutical industry.
• Strong experience in a technical/programming role within the pharmaceutical industry, preferably within Clinical Data Management.

Skills

• Medidata Rave
• Veeva
• Medrio
• Viedoc
• SAS
• PL/SQL
• C#
• VB
• Familiarity with edit checks, derivations, database setup, and data validation processes

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.