Data Transparency Lead

UCB•Raleigh, NC

19h•$148,000 - $194,000•Hybrid

About The Position

UCB is seeking a Data Transparency Lead for its Global Clinical Sciences and Operations team, based in Raleigh, North Carolina. This hybrid role requires at least 40% of work time in the office. The Lead oversees global data transparency activities and helps ensure 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 an internal and external point of contact for transparency guidance and industry best practices, including statistical input on data elements suitable for sharing and anonymization. The Lead builds relationships with stakeholders across Clinical Project Management, Biostatistics, Medical Writing, Regulatory Affairs, Safety, and Information Technology. They work with clinical development teams to integrate transparency planning and meet mandated timelines for clinical trial protocol and results information. The role also supports Disclosure, Quality Control, and Medical Writing teams as needed. Responsibilities include preparing and overseeing transparency documents and anonymization activities; supporting regulatory submissions; collaborating on compliant data sharing; managing vendors, documents, systems, and timelines; maintaining CCI master lists and redaction checklists; and providing quality control. The Lead serves as a subject matter expert on patient-level data anonymization and privacy, supports process and training development, ensures adherence to UCB policies and SOPs, and monitors regulatory and external developments for potential policy updates. 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.

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.
Excellent written and verbal communication skills, including the ability to clearly communicate complex quantitative ideas.
Extensive 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 concurrent tasks.
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.
Considerable judgment to work accurately and efficiently toward quality results and create processes and procedures when necessary.
Proactivity in evaluating study and project reports to detect problematic issues.

Responsibilities

Prepare, lead, and support transparency documents and data anonymization activities, including plain language summaries, data sharing, redactions, anonymization, and regulatory submissions in compliance with SOPs and relevant regulations.
Collaborate with UCB stakeholders to ensure data sharing activities comply with UCB policies and regulatory requirements.
Ensure anonymized submissions and study documentation meet regulatory standards.
Oversee external vendors to ensure high-quality, timely deliverables.
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, and conduct quality control of vendor activities.
Serve as the subject matter expert for patient-level data anonymization and privacy-related issues, identify process improvements, and explain complex technical topics to internal stakeholders.
Contribute to and manage data anonymization and data sharing timelines and study or project commitments.
Provide support and input into the development of 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 support updates to UCB’s Data Transparency policy as needed.
Build working relationships with contributing stakeholders and work with clinical development teams to integrate transparency planning and meet mandated information-availability timelines.
Support Disclosure, Quality Control, and Medical Writing teams as needed.