Clinical Trial Manager (LATAM)

1 day, 22 hours ago
Full-time
Senior
Project and Program Management
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

Description

  • Serve as the primary clinical point of contact for the client.
  • Own the planning, execution, and oversight of clinical studies.
  • Collaborate with project management on monthly invoicing and clinical budget variance management.
  • Develop study-specific clinical documents, templates, manuals, trackers, and training materials.
  • Identify training needs for CRAs and third-party vendors and support investigator and study kick-off meetings.
  • Generate site lists, drive feasibility activities, and develop country-level recruitment and retention strategies.
  • Lead site start-up, enrollment, maintenance, and closeout activities with investigators and study teams.
  • Lead internal clinical team meetings and set expectations for CRAs and CTAs.
  • Oversee submissions and approvals to Competent Authorities and IRB/Ethics Committees.
  • Develop monitoring strategies, track metrics, manage eTMF processes, and support CAPA implementation and audit readiness.

Requirements

  • Bachelor’s degree or equivalent combination of education and experience in a science or health-related field; advanced degree preferred.
  • Minimum of 7 years of clinical research experience with significant clinical monitoring experience.
  • Advanced degree preferred.
  • Experience with Microsoft Office products, including Outlook, Word, Excel, and PowerPoint.
  • Excellent communication and interpersonal skills for effective teamwork and stakeholder interaction.
  • Excellent organizational skills, attention to detail, and a customer service demeanor.
  • Ability to travel domestically and internationally, including overnight stays.
  • Mastery of ICH-GCP, relevant SOPs, and regulatory guidance.
  • Working knowledge of clinical management techniques and tools.
  • Direct experience in a cross-functional environment and proven functional management, delegation, planning, risk management, and change management experience.
  • In-depth proven experience in pharmaceutical and/or device research.
  • Demonstrated ability to negotiate independently and manage conflict effectively.

Benefits

  • Remote work designation (#LI-REMOTE).
  • Significant career growth opportunities, including building teams and taking on broader leadership responsibilities.
  • Opportunity to influence regional processes, culture, and project management scope as the Latin America operation expands.
  • Equal Opportunity Employer status.
  • Reasonable accommodation support during the application process for individuals with disabilities.

Interested in this position?

Apply directly on the company website

Apply Now

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