Records Specialist I

Premier Research

. Perform all departmental budgeted activities for assigned studies .

Posted 11/12/2026full-timeRemote • Spain, Bulgaria, RomaniaMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Clinical Trials Records Management and Trial Master File (TMF) processes, with a strong understanding of global regulations such as ICH-GCP and ISO14155. Proficient in utilizing computerized records management technologies and web-based communication tools to support efficient study operations.

Highest-signal resume keywords

Clinical Trials Records ManagementTrial Master File ManagementETMF System AdministrationGlobal Clinical Trials ExperienceKnowledge of ICH-GCP and ISO14155

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Records ManagementClinical Trials SupportComputerized Records Management TechnologiesWeb-Based Communication ToolsOrganizational SkillsTime ManagementMultitaskingQuality AssuranceAudit SupportTraining Assistance

Soft Skills

Team PlayerCollaborativeIndependent WorkAdaptabilityEffective Communication

Industry Keywords

Pharmaceutical IndustryMedical Device IndustryCRO EnvironmentRecords and Information ManagementLibrary Science

About the role

Key responsibilities & impact

Perform all departmental budgeted activities for assigned studies
Assist with identifying, reporting and resolving quality and efficiency concerns with records management work practices
Understand TMF Plans, TMF indexes, transition plans, and related materials for assigned studies
Assist with live, web-based and/or recorded process and system training for company staff, Sponsors, and/or third parties
Assist with internal and 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 targeted project team meetings globally
Assist with eTMF System Administrator responsibilities as needed
Perform additional duties assigned by the TMF Lead and/or department management

Requirements

What you’ll need

Minimum of a high school diploma or international equivalent required
Undergraduate degree preferred from an accredited institution majoring in records and information management, library science, clinical, science or health related field
Equivalent level of clinical trials records management experience accepted as an alternative to the preferred undergraduate degree
Previous clinical trials records management experience preferred
Previous experience using computerized clinical trials records management technologies preferred
Global clinical trials experience preferred
Clinical trials support or pharmaceutical/medical device industry experience preferred
Knowledge of web-based communication tools for conferences and other required IT systems preferred
Basic knowledge of ICH-GCP, ISO14155 and global regulations pertaining to Trial Master File management preferred
Excellent team player, collaborative and able to work within an effective team
Ability to multitask and work effectively and independently in a fast-paced CRO environment with changing priorities
Ability to read, write, and speak fluent English
Excellent organizational and time-management skills; ability to prioritize work to meet deadlines

Benefits

Comp & perks

Flexibility and balance to support employees' lives
Skills and opportunities for professional growth
Opportunities to excel at work