Records Specialist II

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 is looking for a Records Specialist II to join our Pharmacovigilance and Records Management team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. Your ideas influence the way we work, and your voice matters here. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here.

What You'll Be Doing:

• 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 studie
• 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
• Performing additional duties as assigned by TMF Lead and/or department management

What We Are Looking For:

• Successful experience and results as a Records Specialist I or equivalent in a clinical trials records management setting required.
• 1+ years (2+ years without degree) of clinical trials records management experience required.
• Experience using computerized clinical trials records management technologies required.
• Global clinical trials experience is preferred.
• Knowledge of web-based communication tools for conferences and any other IT systems required for the job is required.
• Knowledge of ICH-GCP, ISO14155 and global regulations pertaining to Trial Master File management is required.
• 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, able prioritize work to meet deadlines.

Premier Research is more than a company - it’s a community furthering research to improve the lives of patients in critical need. We are a diverse staff thinking creatively, challenging ideas, and solving complex problems. Our Values - We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care - mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location. Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning.

Premier Research is a global clinical research, product development, and consulting company. We are dedicated to helping biotech, specialty pharma, and MedTech innovators transform life-changing ideas and breakthrough science into new medical treatments. Our team is inspired by this common purpose. Premier is a place where you can change lives, and feel rewarded and celebrated. We aim high - we will not stop until we reach our goals. And we care about each other, about our customer and partners, and, most importantly, about all the patients that we touch with our work.