Clinical Computer Systems Manager

An opportunity has arisen for an experienced Clinical Computer Systems Manager to lead the digital transformation of our clinical studies processes, moving from paper-based processes to electronic data capture (EDC), electronic trial master files (eTMF), and a clinical trial management system (CTMS). A strong background in clinical trial systems, regulatory compliance, and project management.

This role involves collaborating with Clinical, Systems, Quality and Regulatory teams to implement and optimise clinical systems, ensuring compliance with GCP, MHRA, EMA and GDPR regulations.

Role Responsibilities:

Clinical Systems Implementation & Management

• Define and execute a digital transformation roadmap for clinical systems, ensuring alignment with business strategy and regulatory requirements.
• Lead the selection, validation, and implementation of EDC, eTMF, and CTMS, as appropriate to improve efficiency and to support clinical studies and regulatory requirements.
• Work closely with the Clinical Team to define system requirements, workflows, and individual clinical study needs.
• Lead system configuration, risk assessment, validation (CSV), and user acceptance testing (UAT) to ensure compliance with 21 CFR Part 11, GCP Data Governance, and GDPR.
• Develop and manage Clinical electronic system SOPs, work instructions, and training materials.
• Ensure data security, integrity, and compliance across all clinical study systems and for the system lifecycle.
• Liaise closely with and assist the Clinical Study Data Manager (DM) or perform the role of Data Manager, depending on experience.
• Develop Data Management Plans (DMPs): Outline how data will be collected, cleaned, validated, and reported.
• Ensure accuracy, accessibility, and compliance with regulations by developing and implementing data management policies, procedures, and systems to facilitate efficient clinical and regulatory data collection, tracking and storage solutions.

Training & User Support

• Provide training and ongoing support to Clinical Team transitioning from paper-based processes.
• Act as the primary point of contact for troubleshooting, and system upgrades. Liaise with Systems in respect of System Administrator role.
• Conduct training sessions for all those involved in clinical studies and system use.

Clinical Trial Data & Process Optimization

• Ensure seamless data flow between EDC, eTMF, CTMS, and regulatory submission systems.
• Work with the Clinical Team to standardise processes, improve efficiency, and ensure audit readiness.
• Support the Clinical Team in data cleansing, reconciliation, and quality control.

Regulatory Compliance & Risk Management

• Ensure all clinical systems comply with regulatory standards (MHRA, EMA, GCP).
• Prepare for regulatory audits and inspections, ensuring documentation and system logs are audit ready.
• Conduct periodic system reviews to maintain compliance.

Key Requirements:

Essential:

• Degree in Life Sciences, Computer Science, Health Informatics, or a related field.
• 5+ years of experience managing clinical trial systems (EDC, eTMF, CTMS) within a pharmaceutical, medical device, CRO, or biotech environment.
• Strong knowledge of clinical trial processes, ICH-GCP, ISO 14155:2020, GDPR, and MHRA/EMA regulations.
• Experience in clinical system validation (CSV) and systems vendor selection.
• Excellent project management skills and experience in electronic clinical systems implementation.
• Strong ability to train and support clinical teams during system transitions and throughout electronic system lifecycle.

Desirable:

• Knowledge of AI-driven clinical data management solutions.
• Certification in Clinical Data Management (eg CDISC, DIA, GAMP).
• Knowledge of statistical computer system packages e.g. SAS