EU CTR Submission Group Lead - Baar

Nur für registrierte Mitglieder Baar, Schweiz

vor 1 Monat

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Job summary

The EU-CTR Submissions Group Lead is a critical leadership role overseeing operational activities related to end-to-end trial submissions and lifecycle management under the EU Clinical Trials Regulation (EU CTR 536/2014). The position ensures the efficient, timely, and compliant execution of submissions via the Clinical Trials Information System (CTIS)

Responsibilities

  • Regulatory Submission Leadership: Oversee planning and execution of Initial CTAs, Part I & II submissions, Substantial Modifications (SMs), and lifecycle management in CTIS.
  • Cross-functional collaboration with internal stakeholders.

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