Clinical Scientist, Vaccines – Senior Manager
Pfizer
Manager, Data Disclosure and Transparency
BeOne Medicines
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteSalary
💰 $116,700 - $156,700 per year
Job Level
Mid-LevelSenior
About the role
- Writes, submits, and manages clinical trial registrations, tabular results, lay summaries, and maintenance updates in accordance with BeOne policy and international regulations
- Maintains and updates data disclosure tracking tools and dashboards to comply with registration, results posting, and data sharing requirements
- Manages redaction and anonymization of personal data and confidential information and prepares anonymization reports and justifications
- Facilitates cross-functional team review and approval of transparency submissions on time and within compliance requirements
- Leads and manages special projects involving transparency and provides updates on project status
- Supports Data Sharing Coordination activities and develops/implements processes, standards, and training materials for Data Disclosure & Transparency activities
- Ensures adherence to applicable policies, procedures, and quality standards; may include supervisory responsibilities and vendor management
Requirements
- 5+ years of relevant experience and a BA or BS, or 4+ years with a MA or MS
- Preferably 5 or more years of direct experience in Data Disclosure & Transparency, Regulatory Affairs, or Medical Writing
- Experience with Veeva RIM
- Core understanding and familiarity with clinical trial development process and Data Disclosure/Transparency processes
- Advanced knowledge of clinical trial transparency regulations and ability to keep current with international requirements
- Experience managing redaction and anonymization of personal data and preparing anonymization reports/justifications (EMA Policy 70, Health Canada PRCI)
- Excellent verbal and written communication skills
- Attention to detail, time management, and ability to balance multiple tasks to meet deadlines
- Strategic thinking with focus on process development, improvement and optimization
- Experience in task management, supervising staff, and vendor relationship management (may be applicable)
