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Senior Manager, Clinical Operations

2 hours, 17 minutes ago
Mexico
Senior
Operations Manager
Project and Program Management
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 77

Description

  • Own governance, accountability, alignment, and lifecycle management for Clinical Operations processes across regions and functions.
  • Lead the development, review, harmonization, implementation, and maintenance of SOPs, work instructions, tools, templates, and related documentation.
  • Identify and resolve process gaps, duplication, inconsistencies, conflicting requirements, and unnecessary complexity.
  • Translate regulatory requirements, ICH-GCP principles, quality standards, audit findings, CAPAs, operational data, and stakeholder feedback into practical process solutions.
  • Lead cross-functional process governance and decision-making with Clinical Operations, Quality Assurance, Regulatory, Project Management, Data Management, Biostatistics, Medical, Training, and other teams.
  • Drive process implementation and change management, including impact assessments, stakeholder engagement, training, communications, adoption monitoring, and effectiveness evaluation.
  • Provide senior Clinical Operations subject-matter expertise for audits, inspections, CAPAs, strategic initiatives, process assessments, operational improvements, and business development activities.
  • Contribute Clinical Operations input to proposals, budgets, contracts, and bid defense meetings, and represent operational capabilities to prospective clients.
  • Lead cross-functional working groups, process teams, and strategic improvement initiatives as needed.

Requirements

  • Bachelor’s degree in life sciences, healthcare, clinical research, business, or a related field; equivalent experience may be considered.
  • 5+ years of progressive clinical research or Clinical Operations experience in a CRO, pharmaceutical, biotechnology, or global clinical outsourcing environment.
  • Experience leading complex cross-functional or global process improvement initiatives from assessment and design through implementation and effectiveness evaluation.
  • Strong knowledge of clinical trial operations, clinical monitoring, site management, and cross-functional trial delivery processes.
  • Strong knowledge of ICH-GCP, regulatory expectations, quality standards, and inspection readiness principles.
  • Ability to influence stakeholders, facilitate decisions, resolve conflicting requirements, and drive outcomes in a matrix organization.
  • Experience owning or leading Clinical Operations SOPs, work instructions, and controlled documentation through their lifecycle.
  • Experience with process mapping, change management, Lean, or continuous improvement methodologies.
  • Expert understanding of Clinical Operations processes and cross-functional interfaces.
  • Ability to translate regulatory and quality requirements into clear, proportionate, and operationally practical processes.

Interested in this position?

Apply directly on the company website

Apply Now

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