- Location
- Regional_Argentina
- Workplace
- Remote
- Type
- Full-time
- Department
- Healthcare
- Seniority
- Entry
- Education
- Bachelor
- Source
- Workday
Description
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:
Maintains Trial Master File (TMF)/electronic Trial Master File (eTMF) in collaboration with the clinical team as defined by the organization’s or Sponsor’s SOPs and all applicable regulatory requirements.
Reviews site documents and verifies they meet or exceed all company, sponsor, regulatory authority, and ALCOAC standards.
Conducts follow up with the internal team on TMF queries to ensure timely resolution.
May assist SSUAs/CRAs with essential document collection and review during startup, maintenance and close out.
Assists the clinical study team in the tracking and documentation of Investigator's Brochure and safety report distribution as well as other documents/materials sent to sites, e.g. newsletters.
Supports the CRA/clinical team in liaising with third party vendors to solve and follow-up on issues e.g. on study equipment, translations
What We Are Searching For:
Undergraduate degree required, or its international equivalent in nursing, life sciences or medical documentation from an accredited institution
Fluent verbal and written English
Knowledge of ICH/GCP preferred
Solid computer knowledge/skills including MS Word, Excel, PowerPoint and Outlook
Excellent interpersonal and listening skills
Premier Research is dedicated to providing compensation that is fair and competitive with market standards. The actual salary will be influenced based on a variety of factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. We also offer a comprehensive benefits package, which may include health insurance, retirement plans, and paid time off.
