Senior Transparency Specialist
3 weeks ago
Key Responsibilities
- Provide operational support for clinical trial transparency, data sharing, and redaction/anonymization of clinical trial documents.
- Ensure compliance with regulatory requirements, including EMA Policy 0070, HC PRCI, and EU-CTIS.
- Facilitate the initiation, progression, and completion of transparency workflow steps.
- Perform quality control reviews of document redaction or anonymization to ensure consistency and accuracy.
- Maintain a strong understanding of regulations and guidance's as they pertain to transparency.
- Lead projects with minimal management oversight, including complex projects with multiple team members.
- Tailor communication to diverse audiences, considering experience, background, and expectations.
- Anticipate and understand customer's needs and preferences, providing solutions to customer's needs.
- Effectively manage/prioritize multiple deliverables and delegate as needed or implement workable solutions to complete deliverables on time.
- Capable of leading transparency process/tools improvements initiatives and participating in complex companywide process improvement initiatives.
- Foster a positive team environment while supporting independent action to achieve team goals.
- Bachelor's Degree in a scientific, medical, or clinical discipline or related field is preferred; or 5 years of experience if less than a Bachelor's.
- At least 3 years of previous transparency experience.
- Hands-on experience with clinical trials and pharmaceutical development preferred.
- Effective problem-solving and data analysis skills.
- Experience in the pharmaceutical or CRO industry highly preferred.
- Strong attention to detail.
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