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Manager, Records Management (LATAM)

3 days, 8 hours ago
Mexico, Brazil
Full-time
Lead
Operations Manager
Operations
Apply Now
Precision For Medicine

Precision For Medicine

Precision for Medicine is a specialized scientific services company that helps pharmaceutical and life sciences clients innovate, develop, and commercialize next-generation medical products. With a diverse team of experts, they offer comprehensive serv...

Pharmaceuticals
1K-5K
Founded 2012
$225M raised
View All Jobs 86

Description

  • Oversee a team of Documents Specialists, Quality Review Specialists, and/or TMF Leads responsible for Trial Master File quality.
  • 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 output.
  • Review TMF metrics, system reports, and dashboards to identify process and performance issues.
  • Resolve TMF issues, escalations, and noncompliance cases by leading mitigation and corrective actions.
  • Support audits and inspections, including participation in audit and inspection meetings when needed.
  • Manage staff through regular 1:1s, performance reviews, workload prioritization, training, and development.
  • Participate in hiring decisions, staffing plans, and financial utilization oversight for assigned studies and tasks.
  • Collaborate with leadership and cross-functional stakeholders to improve processes, draft SOPs and work instructions, and promote TMF best practices.

Requirements

  • Bachelor’s degree or international equivalent.
  • Minimum of 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.
  • Established experience using Microsoft Office, including Outlook, Word, Excel, and PowerPoint.
  • Track record of implementing process standardization for tracking and reporting clinical trials.
  • Excellent organizational skills, time management, and ability to meet deadlines.
  • Strong verbal and written communication, problem-solving, and interpersonal skills.
  • Experience with Precision SOPs and the ability to train and retain working knowledge of ICH-GCP and relevant regulatory guidance.

Benefits

  • Remote role with #LI-REMOTE flexibility.
  • Opportunity to build a Records Management team across LATAM.
  • Equal Opportunity Employer status.
  • Reasonable accommodation support for candidates with disabilities.
  • Privacy policy protections for applicant data.

Interested in this position?

Apply directly on the company website

Apply Now

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