Recruitment Data Policies Data Transparency Lead
About The Position
The Data Transparency Lead will oversee global data transparency activities, ensuring compliance with transparency requirements and alignment with scientific and ethical standards. The role leads and supports preparation of data and documents for transparency, disclosure, and data sharing, and serves as the organization’s internal and external point of contact for transparency matters. This includes providing guidance and statistical perspective on useful shareable data elements, anonymization, data sharing, and disclosure. The position works with stakeholders across Clinical Project Management, Biostatistics, Medical Writing, Regulatory Affairs, Safety, and Information Technology, and interacts frequently with clinical development teams to integrate transparency planning and meet mandated timelines. It prepares and supports transparency documents and anonymization activities, oversees vendors and project teams, manages relevant documents and timelines, and contributes to policies, procedures, training, and process improvements. The role is based in Raleigh, North Carolina, and is hybrid, with at least 40% of time in the office. Domestic and international travel may be required as business needs dictate.
Requirements
- At least 5 years of experience with a Master’s degree, or 7 years with a Bachelor’s degree, in data disclosure and transparency roles within Pharma or Biotechnology, including clinical research organizations.
- Specialized knowledge in patient-level data anonymization.
- Excellent written and verbal communication skills, including the ability to communicate complex quantitative ideas clearly.
- Experience communicating with personnel at all levels across departments in domestic and international environments.
- Ability to build relationships, establish trust, and work as a team player.
- Demonstrated experience leading and participating in collaborative teams at local and global levels.
- Advanced understanding of regulatory submission requirements for new product development and support.
- Good project-management skills and attention to detail, including experience leading meetings and managing multiple tasks concurrently.
- Ability to work under pressure and without close supervision.
- Vendor-management experience.
- Ability to travel domestically and internationally as business necessitates.
- Ability to adapt to change and work in a multicultural global environment.
- Ability to work independently and explain complex topics to build consensus.
- Advanced analytical ability, with a structured and methodical approach to sound decision-making.
- Ability to plan, perform, troubleshoot, and make decisions based on precedent, company policies, UCB procedures, national and international regulations, and Good Clinical Practice.
- Judgment to work accurately and efficiently toward quality results and create new processes and procedures when necessary.
- Proactive evaluation of study and project reports to detect problematic issues.
Nice To Haves
- Advanced experience in clinical study design and analysis, including drug-development phases and efficacy and safety assessments.
- In-depth knowledge of global disclosure, transparency, and data sharing.
Responsibilities
- Prepare, lead, and support transparency documents and data anonymization activities, including plain language summaries, data sharing, redactions, anonymization, and regulatory submissions.
- Ensure transparency activities comply with SOPs, FDA, EMEA, ICH, other relevant regulations, UCB policies, and regulatory requirements.
- Ensure anonymized submissions and study documentation meet regulatory standards.
- Collaborate with UCB stakeholders to ensure data-sharing activities comply with applicable policies and regulations.
- Oversee external vendors to ensure high-quality and timely deliverables, and perform quality control of vendor activities.
- Manage documents and interface with UCB systems to maintain final documents, track activities, and meet deadlines.
- Maintain Commercially Confidential Information (CCI) master lists and redaction checklists.
- Serve as the subject matter expert for patient-level data anonymization and privacy-related issues, and identify process improvements and solutions.
- Explain complex and technical topics to internal stakeholders.
- Contribute to and manage data-anonymization and data-sharing timelines and project commitments.
- Provide support and input into developing SOPs, processes, and training for Data Transparency.
- Oversee project teams to ensure adherence to UCB’s Data Transparency Policy and SOPs.
- Monitor the external landscape and regulatory environment and identify and support necessary updates to UCB’s Data Transparency policy.
- Develop and maintain working relationships with contributing stakeholders, including Clinical Project Management, Biostatistics, Medical Writing, Regulatory Affairs, Safety, and Information Technology.
- Work with clinical development teams to promote awareness of transparency requirements and integrate planning for timely availability of clinical trial protocol and results information.
- Support Disclosure, Quality Control, and Medical Writing teams as needed.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
