Related skills
budgeting tmf ich-gcp informed-consent-form📋 Description
- Deliver site activation readiness for assigned country/sites.
- Mitigate risks to ensure timely trial start-up.
- Prepare CTAs and submission dossiers for authorities.
- Interact with Competent Authorities and Ethics Committees.
- Update Start Up/Regulatory leads and PM on submissions.
- Maintain project plans, trackers and regulatory tools.
🎯 Requirements
- Experience as Regulatory/Start Up specialist in CRO or pharma.
- Experience customizing ICFs for Italy.
- Bachelor’s degree in life sciences or RN or equivalent.
- Contracts and budgeting negotiation experience.
- Strong communication and organizational skills.
- Experience using electronic spreadsheets, word processing and email.
- Fluency in English and local language.
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