Records Specialist II

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.