Records Specialist II

This is a fully remote position, open to applicants in Spain, +2 more countries.

📋 Description

• Execute all budgeted departmental activities for designated studies

• Aid in identifying, reporting, and addressing quality and efficiency issues related to records management practices

• Comprehend TMF Plans, TMF indexes, and transition strategies for assigned studies

• Provide support for live, web-based, and/or recorded training on processes and systems for company personnel, Sponsors, and/or third parties

• Assist with global internal and external audits and inspections for assigned studies

• Support office-based and/or off-site corporate archives regionally as required

• Help conduct system demonstrations, study KOMs, and other focused project team meetings globally

• Contribute to eTMF System Administrator duties as needed

• Undertake additional responsibilities as assigned by the TMF Lead and/or department management

⛳️ Requirements

• Proven experience and success as a Records Specialist I or in a similar role within a clinical trials records management environment is essential

• A minimum of 1 year of clinical trials records management experience is required; 2+ years if not holding a degree

• Proficiency in using computerized clinical trials records management technologies is required

• Experience with global clinical trials is preferred

• Familiarity with web-based communication tools for conferences and other necessary IT systems

• Understanding of ICH-GCP, ISO14155, and international regulations related to Trial Master File management

• Strong team player, collaborative, and capable of functioning within an effective team

• Ability to handle multiple tasks and work efficiently and independently in a dynamic CRO environment with shifting priorities

• Proficient in reading, writing, and speaking fluent English

• Exceptional organizational and time-management skills; capable of prioritizing tasks to meet deadlines

🏝️ Benefits

• Flexibility and balance to accommodate your personal life requirements

• Opportunities for professional development and skill enhancement