Local Study Associate Director

medizinstellenmarkt.de

Lead local study team at country level
Ensure compliance with ich-gcp guidelines
Manage site identification and qualification
The role requires leading Local Study Teams to deliver clinical study components according to agreed resources, budgets, and timelines while ensuring strict compliance with international guidelines

Job Summary

  • The role requires leading Local Study Teams to deliver clinical study components according to agreed resources, budgets, and timelines while ensuring strict compliance with international guidelines.
  • Responsibilities include overseeing the entire site lifecycle from identification and qualification through initiation, monitoring, and closure, as well as managing financial agreements and regulatory submissions.
  • Candidates must demonstrate excellent project and risk management skills to proactively identify complex study problems and facilitate their resolution within a cross-functional team environment.

Matching Summary

The role requires leading Local Study Teams to deliver clinical study components according to agreed resources, budgets, and timelines while ensuring strict compliance with international guidelines.

Skills & Requirements

Must-have

  • Lead Local Study Team at country level
  • Ensure compliance with ICH-GCP guidelines
  • Manage site identification and qualification
  • Oversee clinical study budget and timelines
  • Coordinate regulatory submissions to EC/IRB
  • Develop risk management plans for studies

Nice-to-have

  • Ability to use Artificial Intelligence tools
  • Experience in AstraZeneca therapeutic areas
  • Strong negotiation skills with stakeholders
  • Coaching and mentoring junior colleagues
  • Intercultural awareness in global teams

Key Requirements

  • Bachelor degree in life science or related discipline
  • Minimum 5 years experience in Development Operations or CRA roles
  • Proven ability to lead cross-functional clinical trial teams
  • Excellent knowledge of ICH-GCP and local regulations
  • Fluency in spoken and written English

Work Rights

No foreign travel disqualifications required

Tailored Resume

Cover Letter