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Director, Site Start Up

2 months ago
China, Australia, Singapore, South Korea, Taiwan
Full-time
Executive
Program 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 31

Description

  • Provide leadership, guidance, and overall support to the Site Start-up team.
  • Drive the strategy, structure, and expansion of the Site Start-up department across people, processes, and systems.
  • Oversee site start-up delivery through direct management and cross-functional coordination of IRB/EC/CA submissions, site contracts, and budget negotiations.
  • Work with the Head of Site Start Up to establish the SSU framework, including tools, methodology, risk evaluation, and mitigation.
  • Collaborate with Clinical Operations, project management, and other functions to plan, execute, and govern SSU activities globally and regionally.
  • Manage escalations and remediate site start-up issues in a timely and effective manner.
  • Support optimization of SSU processes to improve delivery, profitability, and budget performance.
  • Partner with Global Resourcing teams to assess and manage SSU leads, specialists, and site contract staff against cost, time, and quality goals.
  • Support career development, growth, and succession planning for SSU team members.
  • Develop, measure, and report SSU KPIs and lead continuous improvement efforts.

Requirements

  • Bachelor’s degree in life sciences or a related field, or equivalent education, training, and experience.
  • Minimum 12 years of clinical research experience, including extensive site start-up experience.
  • Extensive leadership experience or demonstrated competencies for the role.
  • Expert knowledge of GCP/ICH guidelines and the clinical development process.
  • Demonstrated leadership track record.
  • Experience working in a team environment with resource management responsibility.
  • Proficiency with Microsoft Office products, including Outlook, Word, Excel, and PowerPoint.
  • Experience with clinical software such as CTMS, eTMF, and EDC.
  • Excellent communication and interpersonal skills for team-based collaboration.
  • Strong organizational skills, attention to detail, customer service mindset, and fluency in English.

Interested in this position?

Apply directly on the company website

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