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Clinical Computer Systems Manager

1 week ago

Hertfordshire, United Kingdom CK Group Full time

Clinical Computer Systems Manager

CK Group are working with a long established and successful pharmaceutical company in Hertfordshire. They are about to transition from paper-based clinical study processes, to a fully electronic system and are looking for a permanent Clinical Computer Systems Manager to oversee that.

This will be fully office based in Hertfordshire to start with, but can go down to three days a week in the office once settled in.

RESPONSIBILITIES:

As Clinical Computer Systems Manager you will collaborate closely with colleagues in Clinical, Regulatory, Quality and Systems to implement and optimise electronic clinical systems, ensuring compliance with GCP, MHRA, EMA and GDPR regulations.

Key duties will include:

Defining and executing a digital transformation roadmap for clinical systems. Leading the selection, validation and implementation of EDC, eTMF and CTMS to improve efficiency and support clinical and regulatory requirements. Working closely with the clinical team to define system requirements, workflows and individual clinical study needs. Leading system configuration, validation and User Acceptance Testing to ensure compliance with 21 CFR Part 11, GCP Data Governance and GDPR. Developing and managing clinical electronic system SOPs, work instructions and training materials. Ensuring data security, integrity and compliance across all clinical systems for the system lifecycle.

QUALIFICATIONS:

As Clinical Computer Systems Manager you will require:

A relevant life science, computer science or similar degree. Extensive experience of managing electronic clinical trials system such as EDC, eTMF, CTMS etc. An in-depth knowledge of clinical trial processes, ICH-GCP, GDPR, ISO 14155:2020 and MHRA/EMA regulations. Experience of Computer System Validation and systems vendor selection. Excellent project management skills. The ability to train and support clinical teams during system transitions and throughout the electronic system lifecycle.

BENEFITS:

Competitive salary.