Global Records Specialist II — Pharmacovigilance & TMF

46 Premier Research Group SL; España; On-site; EUR 32,000 - 42,000; Full time

Job summary

Premier Research seeks a Records Specialist II to join our Pharmacovigilance and Records Management team. You will help biotech and pharma clients transform ideas into new medicines and diagnostics, ensuring robust TMF practices and regulatory compliance.

The role focuses on supporting TMF plans, participating in audits, trainings, and cross-functional teams within a fast-paced CRO environment. Fluency in English and strong organizational skills are essential.

Qualifications

• Experience in a clinical trials records management setting.
• 1+ years (2+ years without degree) of clinical trials records management experience.
• Experience using computerized clinical trials records management technologies.
• Global clinical trials experience preferred.
• Knowledge of web-based communication tools for conferences and IT systems.
• Knowledge of ICH-GCP, ISO14155 and global TMF regulations.

Responsibilities

• Performing all departmental budgeted activities for assigned studies.
• Assisting with identifying, reporting and resolving quality and efficiency concerns with records management work practices.
• Understanding TMF Plans, TMF indexes, transition plans, etc. for assigned studies.
• Assisting with live, web-based and/or recorded process and/or system training for company staff, Sponsors and/or third parties for assigned studies.
• Assisting with internal/external audits and inspections globally for assigned studies.
• Assisting with office based and/or off-site corporate archives regionally as needed.
• Assisting with system demonstrations, study KOMs and other targeted project team meetings globally for assigned studies.
• Assisting with eTMF System Administrator responsibilities as needed.

Skills

Clinical trials records management

TMF / Trial Master File

ICH-GCP / ISO14155

Web-based conferencing tools

Global regulatory knowledge

Teamwork

Time management

English fluency

Multitasking

Job description

Premier Research seeks a Records Specialist II to join our Pharmacovigilance and Records Management team. You will help biotech and pharma clients transform ideas into new medicines and diagnostics, ensuring robust TMF practices and regulatory compliance.

The role focuses on supporting TMF plans, participating in audits, trainings, and cross-functional teams within a fast-paced CRO environment. Fluency in English and strong organizational skills are essential.