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Director, Site Start up

5 days, 4 hours ago
Serbia, Slovakia, Spain, United Kingdom, Poland, Romania, Hungary
Full-time
Executive
Operations 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 84

Description

  • Provide leadership and overall support to the Site Start-up team across project delivery, communication, resourcing, and process improvement.
  • Oversee site start-up delivery across IRB/EC and Competent Authority submissions, site contracts, budget negotiations, and related start-up activities.
  • Work with the Head of Site Start Up to define and expand the SSU framework, including tools, methodology, risk evaluation, and mitigation.
  • Collaborate with Clinical Operations, project management, and other cross-functional teams to plan, execute, and govern SSU activities globally or regionally.
  • Lead large and complex SSU programs and manage escalations and remediation of SSU issues.
  • Optimize SSU processes and delivery to support 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 team development, career growth, succession planning, and retention.
  • Collaborate with Business Development on proposals, budgeting, and bid defense preparation.
  • Develop, measure, and report SSU KPIs and drive continuous improvement.

Requirements

  • Bachelor’s degree in life sciences or a related field, or equivalent education, training, and experience.
  • At least 12 years of clinical research experience, including extensive site start-up experience.
  • Experience working for a Clinical Research Organisation (CRO).
  • People management experience.
  • 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 (Outlook, Word, Excel, PowerPoint) and clinical systems such as CTMS, eTMF, and EDC.
  • Excellent communication, interpersonal, organizational, and attention-to-detail skills.
  • Proven experience in strategic planning, risk management, and change management.
  • Fluency in English.

Benefits

  • Remote work available in the UK, Spain, Poland, Hungary, Serbia, Slovakia, or Romania.
  • Equal opportunity employer environment.
  • Reasonable accommodation support for applicants with disabilities.

Interested in this position?

Apply directly on the company website

Apply Now

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