IT Manager - Clinical & Safety Systems (iCMR)

Við leitum að IT Manager sem ber ábyrgð á innleiðingu, þróun og umsjón með líftíma lykil‑GxP klínískra tæknikerfa, þar á meðal Veeva Safety, Veeva CTMS og klínískum gagnalausnum eins og EDC og RTSM, auk kerfa sem styðja við bioanalytical‑ og biometrics‑starfsemi.Hlutverkið felur í sér náið samstarf við Clinical Operations, Safety/PV, Data Management, Biostatistics, Bioanalytical og QA til að tryggja lausnir sem eru hentugar, í samræmi við regluverk, og afhentar á réttum tíma innan fjárhagsramma.

(English)

The IT Manager, iCMR is responsible for the implementation, enhancement, and lifecycle ownership of key GxP clinical technology platforms—including Veeva Safety, Veeva CTMS, and clinical data solutions such as EDC and RTSM—as well as enabling bioanalytical and biometrics capabilities. This role partners closely with Clinical Operations, Safety/PV, Data Management, Biostatistics, Bioanalytical, and QA to deliver fit‑for‑purpose, compliant solutions on time and within budget.

Scope and Responsibilities

• Own the product roadmap for Safety and Clinical platforms.

• Establish and run system support operations, including incident triage and CAPA management.

• Lead implementations, upgrades, and change requests.

• Partner with clinical data management and biometrics to enable clean data acquisition and analytics-ready pipelines.

• Ensure compliance with ICH-GCP, GVP, 21 CFR Part 11, EU Annex 11, and data privacy standards.

• Serve as IT point‑of‑contact for Clinical Ops, Safety/PV, Clinical Data Management, and Biometrics.

• Oversee system configuration, validation, integrations, data governance and managed services.

• Contribute to continuous improvement and process harmonization across clinical systems.

Job Requirements

• 5+ years in IT supporting clinical and/or safety platforms.

• 2+ years of experience leading teams or projects

• Handson experience with clinical trial management systems and/or safety/pharmacovigilance systems

• Strong knowledge of CSV, GxP audits, and global clinical operations models.

• Strong communication and stakeholder management skills.

• Bachelor’s degree required

Preferred Qualifications:

• Handson experience with Veeva platforms

• Exposure to bioanalytical data pipelines and biometrics workflows.