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GenentechPosted 1 week ago

Study Start Up Lead

On-siteBuenos Aires, Buenos Aires F.D., Argentina

Full TimeSenior LevelEnterprise

Job Summary

Develop and implement effective study start-up strategies ensuring timely and compliant trial initiation. Oversee start-up operations including site activation, regulatory coordination, and the preparation, submission, and archiving of Informed Consent Forms. Manage clinical trial submissions, amendments, and site documentation while driving process improvements through automation and standardization. Lead budget planning, contract management, and payment processes to ensure legal and financial compliance. Collaborate with CROs, authorities, and industry stakeholders to improve timelines and influence the clinical trial environment. Requires a life sciences degree with postgraduate experience in clinical trial start-up and regulatory submissions. Fluency in English and Spanish is required.

Required Qualifications

  • Degree in life sciences (MD, PhD, MSc, or equivalent)
  • Proven experience in clinical trial start-up, regulatory submissions, and vendor/CRO management
  • Strong knowledge of ICH-GCP, EU CTR, and local regulatory frameworks
  • Fluency in English and Spanish, both written and spoken

Desired Qualifications

  • Postgraduate degree

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