6 дней назад
Senior Clinical Trial Transparency Specialist
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Clinical Trial Transparency Specialist (Clinical Research): Leading clinical trial transparency projects and producing high-quality deliverables for clinical trial data sharing, document redaction, and anonymization with an accent on global regulatory requirements and client delivery. Focus on independently managing complex projects, applying EMA Policy 0070, HC PRCI, and EU-CTIS requirements, and ensuring accurate quality control across multiple deliverables.
Location: Remote or hybrid
Company
is a data-focused clinical research organization supporting pharmaceutical, biotech, and medical device companies with clinical trial data and regulatory submission challenges.
What you will do
- Serve as the primary client contact for assigned clinical trial transparency projects.
- Lead client meetings, clarify requirements, communicate progress, and resolve project-related questions.
- Develop and review transparency deliverables in line with client specifications and agreed timelines.
- Apply global transparency requirements, including EMA Policy 0070, HC PRCI, and EU-CTIS.
- Perform quality control reviews of document redaction and anonymization for consistency and accuracy.
- Lead complex projects, coordinate multiple team members, prioritize deliverables, and support process improvement initiatives.
Requirements
- At least 5 years of previous clinical trial transparency experience.
- Bachelor’s degree in a scientific, medical, clinical, or related field preferred, or 5 years of experience without a bachelor’s degree.
- Experience with clinical trials and pharmaceutical development preferred.
- Experience in the pharmaceutical or CRO industry highly preferred.
- Strong problem-solving, data analysis, communication, and attention-to-detail skills.
Culture & Benefits
- Supportive, collaborative, and inclusive work environment.
- Remote or hybrid working arrangement.
- Opportunity to contribute to clinical research and transparency initiatives across a global organization.
- Recognized Great Place to Work organization with a focus on employee retention.
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