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