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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
