TMF Lead I

Records ManagementRemote, Romania


Position at Premier Research

Premier Research is looking for a TML Lead I to join our Global 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 Built for You. 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.
  • We are Built by You.  Your ideas influence the way we work, and your voice matters here
  • We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Together, we are Built for BiotechSM .Join us and build your future here.         
What you’ll be doing:    
  • Ensures personal utilization targets and study performance metrics are met
  • Acts as primary point of contact for project teams, Sponsors, auditors and other external third parties on assigned studies/programs
  • Supervises department team on assigned studies/programs as needed
  • Ensures performance metrics are met and scope of work is performed according to budgets and timelines for assigned studies/programs for supervised staff as required
  • Ensures that any out-of-scope activities are identified, reported to department management, itemized with project leadership and appropriately budgeted in change orders for assigned studies/programs
  • Leads and/or assists management with department continuous improvement activities globally
  • Supervises the security, environment and access control of Secure File Room (SFR) facilities located in their local office or region (if applicable)
  • Oversees Project Team compliance to essential document management requirements, TMF SOPs and TMF Plans for assigned studies/programs and supervised staff
  • Provides mentoring and training of new hires, project teams and external staff as needed
  • Performs all departmental budgeted activities for assigned studies/programs
  • Assists management with candidate review, interviews, hiring recommendations,
  • Assists with on-boarding and training of department staff globally
  • Serves as primary point of contact for programs and providing program level customer service and support for key Sponsor relationships
  • Participates in business development presentations and system demonstrations, study KOMs and other targeted project team meetings globally as needed
  • Performs eTMF System Administrator responsibilities as needed

What We Are Searching For:  

  • Undergraduate degree or international equivalent from an accredited institution majoring in records and information management, library science, clinical, science or health related field required - or – an equivalent level of clinical trials records management experience.
  • 6+ years (of clinical trials essential document management and/or records management experience is required.
  • Significant experience using computerized clinical trials records management technologies is required.
  • Project, clinical and/or quality management experience preferred.
  • Significant knowledge of ICH-GCP, ISO14155 and global regulations pertaining to essential document management and Trial Master File management is required.
Why Choose Premier Research? 
  • Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need. 
  • Our cultural anchors – Caring & Empathy, Empowerment, Aspiration, One Team – mirror the 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 opportunities so that they have the tools they need to be successful.
Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.
 We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.