Records Specialist I

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

📋 Description

• Execute all budgeted activities for assigned departmental studies.

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

• Comprehend TMF Plans, TMF indexes, transition strategies, and associated materials for designated studies.

• Support live, web-based, and/or recorded training sessions for company personnel, Sponsors, and/or external parties.

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

• Provide support for office-based and/or regional corporate archives as required.

• Help facilitate system demonstrations, study KOMs, and various targeted project team meetings globally.

• Assist with eTMF System Administrator duties as necessary.

• Undertake additional responsibilities assigned by the TMF Lead and/or departmental management.

⛳️ Requirements

• A minimum of a high school diploma or its international equivalent is required.

• An undergraduate degree from an accredited institution in records and information management, library science, clinical, science, or a health-related field is preferred.

• Equivalent experience in clinical trials records management may be considered in lieu of the preferred undergraduate degree.

• Prior experience in clinical trials records management is preferred.

• Experience with computerized clinical trials records management technologies is preferred.

• Global clinical trials experience is preferred.

• Background in clinical trials support or within the pharmaceutical/medical device industry is preferred.

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

• Basic knowledge of ICH-GCP, ISO14155, and global regulations related to Trial Master File management is preferred.

• A strong team player who is collaborative and can function effectively within a team environment.

• Capable of multitasking and working efficiently and independently in a dynamic CRO environment with shifting priorities.

• Proficient in reading, writing, and speaking fluent English.

• Strong organizational and time-management skills; able to prioritize tasks to meet deadlines.

🏝️ Benefits

• Flexibility and balance to support employees' personal lives.

• Opportunities for professional development and skill enhancement.

• Chances to excel in your career.