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Director, Study Start Up -EU

Remote from Spain·Full-time·Added 2 days ago (last checked 15 Nov)

Premier Research

13 open roles

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Our summary

Work mode
Remote from Spain
Contract
Full-time
Experience
7+ years
Education
University degree

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Skills

Requirements

What we're looking for

  • Bachelor's degree, or its international equivalent from an accredited institution, in a clinical, scientific or health related field
  • 7-9 years of related experience (health sciences); clinical trials support or pharmaceutical industry experience preferred
  • Expertise in ICH/GCP and/or ISO14155 requirements as well as detailed knowledge of the relevant country specific regulatory drug/device research and development requirements for conducting clinical trials
  • Working knowledge of FDA, European Regulatory and EC procedures as applicable
  • Knowledge of site and institution specific contract requirements

Nice to have

  • Direct experience in study start up roles highly preferred
  • 5-7 years of personnel management, oversight of larger groups preferred.

The role

Premier Research is looking for a Director, Study Start Up -EU to join our Clinical Monitoring and Site Management team.

You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

  • As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

What you'll do

  • Provides immediate oversight for the SSU performance and teams within the assigned region/s.
  • Manages staffing, and resources to ensure departmental utilization within region
  • Drives SSU teams to meet project timelines
  • Helps the SSU team to improve about their job knowledge, presentation skills and accountability.
  • Partners with VP to determine, improve, streamline, and apply global efficiencies and processes for SSU
  • Closely collaborates with the SSU mgmt. within the US and in other regions to work towards same goals, objectives in a consistent manner
  • Ensures that the SSU process is proactive and completed according to contractual agreement
  • Exercises principles of risk management

About Premier Research

Industry
Pharma

In their own words

About the company & team

  • We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.

  • Your ideas influence the way we work, and your voice matters here.

Join us and build your future here.

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