2 месяца назад
Senior Clinical Trial Associate (Pharmaceuticals)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Clinical Trial Associate (Pharmaceuticals): Assisting with the day-to-day management of global clinical studies with an accent on quality compliance and regulatory documentation. Focus on maintaining the Trial Master File (TMF), coordinating with CROs, and ensuring strict adherence to GCP/ICH standards.
Location: Must be based in either the United States or Denmark
Company
is a pharmaceutical company dedicated to the development and management of clinical studies.
What you will do
- Support the day-to-day management of global clinical studies under the supervision of the Head of Clinical Operations.
- Maintain, QC, and archive the Trial Master File (TMF) and electronic study files.
- Collaborate with CROs to compile and review Investigator Initiation Packets and required regulatory documents.
- Provide administrative support, including organizing meetings, tracking action items, and preparing presentation materials.
- Manage vendor and investigator invoices, including processing and monthly financial reconciliation.
- Ensure all study actions comply with GCP, ICH, and Federal Regulations.
Requirements
- College degree in a relevant field or equivalent direct industry experience.
- At least 5 years of industry experience working with global clinical studies across different phases.
- Strong working knowledge of GCP standards, ICH, and Federal Regulations.
- Proficiency in Microsoft Office Suite (Word, Excel, Project, PowerPoint).
- Ability to work effectively in cross-functional teams and adapt to changing priorities.
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