Walker Cole International is searching for a Clinical Systems Manager to join a Pharmaceutical business based in the Hertfordshire region. This role will involve the transition of a paper-based system to something fully electronic via cross-collaboration with a wide variety of internal stakeholders. You will be responsible for: Establishing a digital roadmap for the transformation of the clinical systems across the business Lead validation and implementation of appropriate systems to improve efficiency and support on studies Act as the primary point of contact for the systems on site, conducting training sessions when required Ensure compliance with all regulatory standards, to prepare for audits and inspections The successful candidate must demonstrate the following: Degree within the Life Sciences of Computer Science field Prior experience working with clinical trial systems within a pharmaceutical, medical device or CRO environment Extensive knowledge of clinical trial processes, systems and regulations (ICH-GCP, GDPR, MHRA, EMA) Prior experience in CSV activities and vendor selection GxP | GCP | Good Clinical Practice | MHRA | EMA | GDPR | Clinical Trial | CRO | CSV | Computer System Validation | eTMF | 21 CFR Part 11 | Electronic Trial Master File | Quality System | QMS | Clinical Trial System