Senior Manager, Clinical Trial Management

19 hours, 8 minutes ago
Full-time
Lead
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

  • Lead, mentor, coach, and manage Clinical Trial Managers and related staff to support performance, skill development, and career growth.
  • Provide leadership and oversight across clinical programs, including clinical trial oversight where applicable.
  • Partner with Clinical Operations leadership and cross-functional teams to improve CTM processes, quality, consistency, efficiency, and KPI achievement.
  • Collaborate with Resourcing to ensure appropriate staffing and resource allocation.
  • Set strategic action plans and provide ongoing performance feedback, technical guidance, and developmental support to direct reports.
  • Ensure CTMs have appropriate training, tools, systems access, and resources to meet role expectations.
  • Identify quality risks, recommend corrective actions, and escalate issues to leadership, PMs, and DPMs as needed.
  • Ensure compliance with SOPs, regulatory requirements, project plans, and quality standards.
  • Develop and update Clinical Operations SOPs, templates, and work instructions, and contribute to clinical documentation as needed.
  • Support CTM hiring, onboarding, and training in collaboration with HR and Learning & Development.

Requirements

  • Graduate, postgraduate, 4-year college degree, or equivalent experience, ideally in a scientific or health-related field.
  • 10 years of industry experience in clinical research, including clinical operations experience in a pharmaceutical company or CRO, or proven competencies for the position.
  • Experience managing the clinical aspects of complex and global trials.
  • Previous CTM line management experience.
  • Working knowledge of ICH GCP guidelines and the clinical development process.
  • Excellent communication and interpersonal skills for effective team collaboration.
  • Excellent organizational skills, attention to detail, and a customer service demeanor.
  • Experience with Microsoft Office products, including Outlook, Word, Excel, and PowerPoint.
  • Ability to travel domestically and internationally, including overnight stays.
  • Direct work experience in a global, cross-functional clinical management environment.
  • Proven people management experience with a high capacity for emotional intelligence.
  • Ability to develop, coach, and mentor CTM staff and hold personnel accountable to goals and training needs.
  • Proven experience in risk management and change management.
  • High level of integrity and ability to inspire high standards from assigned CTMs.
  • Strong self-motivation and ability to work independently as well as in a team environment.
  • Excellent time management, negotiation, critical thinking, decision-making, analytical, and interpersonal skills.
  • Excellent presentation, verbal, and written communication skills.
  • Demonstrated success in independent negotiation and conflict management strategies.
  • High degree of professionalism, including punctuality, commitment delivery, service orientation, and positive customer and team interactions.

Benefits

  • Fully remote work from Spain.
  • Equal Opportunity Employer status with protections against discrimination.
  • Reasonable accommodation available for applicants with disabilities during the application process.

Interested in this position?

Apply directly on the company website

Apply Now

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