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Manager, Records Management (LATAM)

3 hours, 37 minutes ago
Mexico, Brazil
Full-time
Lead
Operations Manager
Project and Program Management
Apply Now
Precision Medicine Group

Precision Medicine Group

Precision Medicine Group specializes in precision medicine, utilizing targeted expertise and data insights to accelerate drug development and enhance the commercialization of next-generation medical products for the pharmaceutical and life sciences ind...

Pharmaceuticals
251-1K
Founded 2012
View All Jobs 110

Description

  • Oversee a team of Documents Specialists, Quality Review Specialists, and/or TMF Leads responsible for TMF quality and document management.
  • Review study TMF Plans and TMF Document Indexes to align team activities with study-specific requirements.
  • Ensure essential clinical study documents are properly filed in the eTMF in accordance with GCP, regulations, and SOPs.
  • Perform periodic and random quality and completeness checks of team work.
  • Review TMF metrics, identify process and performance issues, and support corrective actions.
  • Resolve TMF-related escalations, cross-functional questions, and compliance issues with project teams and sponsors.
  • Support audits and inspections, including attending meetings when needed.
  • Manage team performance through 1:1s, feedback, performance reviews, training, and development planning.
  • Lead staffing decisions, interviews, hiring, workload prioritization, and utilization planning.
  • Support process improvement efforts, SOP/work instruction development, and TMF best-practice adoption across Clinical Solutions.

Requirements

  • Bachelor’s degree or international equivalent.
  • Minimum 8 years of related experience, including at least 2 years in a leadership role.
  • Professional working proficiency in English.
  • Experience with eTMF systems and vendors.
  • Working knowledge of FDA and ICH/GCP regulations and guidelines.
  • Experience implementing process standardization and reporting for clinical trials.
  • Proficiency with Microsoft Office, including Outlook, Word, Excel, and PowerPoint.
  • Strong organizational, time management, communication, and problem-solving skills.
  • Ability to work independently and collaboratively, with strong attention to detail and professionalism.
  • Ability to train and retain knowledge of ICH-GCP, Precision SOPs, and regulatory guidance.

Benefits

  • Remote position (#LI-REMOTE).
  • Opportunity to build and lead a Records Management team across LATAM.
  • Equal Opportunity Employer status.
  • Reasonable accommodation support for applicants with disabilities.
  • Privacy protections for applicants, including a California Privacy Notice.

Interested in this position?

Apply directly on the company website

Apply Now

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