Records Specialist I: Clinical Trials Records & Compliance

46 Premier Research Group SL; España; On-site; EUR 30,000 - 42,000; Full time

Job summary

Premier Research is seeking a Records Specialist I to join our Pharmacovigilance and Records Management team. You will help biotech, medtech, and specialty pharma companies transform ideas into medicines, devices, and diagnostics. The role emphasizes TMF plans, audits, and training across global studies.

You will support live and web-based trainings, assist with audits, and help manage TMF indexes and transition plans while maintaining high data accuracy and regulatory compliance.

Qualifications

• High school diploma required; degree preferred in records/health field.
• Experience in clinical trials records management preferred.
• Experience with computerized trials records management technologies preferred.
• Global clinical trials experience preferred.
• Pharma/medical device industry experience preferred.
• Familiarity with TMF regs and ICH-GCP/ISO14155 preferred.
• Excellent teamwork, organization, and time management.

Responsibilities

• Perform departmental budgeted activities for assigned studies.
• Identify, report and resolve quality and efficiency concerns with records management.
• Understand TMF Plans, TMF indexes, transition plans for assigned studies.
• Assist with live, web-based and/or recorded training for staff, Sponsors and/or third parties.
• Assist with internal/external audits and inspections globally for assigned studies.
• Assist with office-based and/or off-site corporate archives regionally as needed.
• Assist with system demonstrations, study KOMs and other project meetings globally.
• Assist with eTMF System Administrator responsibilities as needed.
• Perform additional duties as assigned by TMF Lead and/or department management.

Skills

Fluent English

Team collaboration

Time management

Independent worker

Attention to detail

Education

High school diploma

Undergraduate degree in records / information management or related field

Clinical trials records management experience

Job description

Premier Research is seeking a Records Specialist I to join our Pharmacovigilance and Records Management team. You will help biotech, medtech, and specialty pharma companies transform ideas into medicines, devices, and diagnostics. The role emphasizes TMF plans, audits, and training across global studies.

You will support live and web-based trainings, assist with audits, and help manage TMF indexes and transition plans while maintaining high data accuracy and regulatory compliance.