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Director, Site Start Up

10 hours, 52 minutes ago
China, Australia, Singapore, South Korea, Taiwan
Full-time
Lead
Program 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 84

Description

  • Provide leadership and overall support for Site Start-Up project delivery, communication, resourcing, and process execution.
  • Oversee site start-up activities including IRB/EC/CA submissions, regulatory document collection and review, and site contract and budget negotiations.
  • Collaborate with the Head of Site Start Up to define and evolve the SSU framework, tools, methodology, and risk mitigation approach.
  • Partner with Clinical Operations, Project Management, and other functions to plan, execute, and govern SSU activities globally and regionally.
  • Lead large and complex SSU programs and manage escalations, remediation, and delivery issues.
  • Support process optimization and continuous improvement to help meet profitability and budget targets.
  • Partner with Global Resourcing to assess and manage SSU team members and ensure cost, time, and quality goals are met.
  • Support career development, growth, and succession planning for the SSU team.
  • Collaborate with Business Development on proposals, budgeting, bid defenses, and client presentations.
  • Develop, measure, and report SSU KPIs and lead continuous improvement initiatives.

Requirements

  • Bachelor’s degree in life sciences or related field, or equivalent education, training, and experience.
  • Minimum of 12 years in clinical research, including extensive site start-up experience.
  • Extensive leadership experience or proven 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 experience.
  • Experience with Microsoft Office products (Outlook, Word, Excel, PowerPoint) and clinical software such as CTMS, eTMF, and EDC.
  • Excellent communication and interpersonal skills.
  • Strong organizational skills, attention to detail, and customer service demeanor.
  • Proven experience in strategic planning, risk management, and change management.
  • Fluency in English.

Interested in this position?

Apply directly on the company website

Apply Now

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