Data Transparency Lead

UCB Inc.; Raleigh (NC); Híbrido; USD 148.000 - 194.000; Jornada completa

Descripción de la vacante

UCB Inc. is seeking a Data Transparency Lead in Raleigh, NC hybrid role. You will oversee global data transparency activities, ensuring compliance with transparency requirements and alignment with scientific/ethical standards, including disclosure and data sharing.

You will lead data anonymization, collaborate with Clinical Project Management, Biostatistics, Medical Writing, and Regulatory Affairs, and manage external vendors to deliver timely, compliant documents.

Formación

• 5+ years in data disclosure and transparency roles in pharma/biotech.
• Experience with anonymization of patient-level data.
• Knowledge of regulatory submission requirements.

Responsabilidades

• Prepare and lead transparency documents and data anonymization activities in compliance with SOPs and regulations.
• Ensure anonymized submissions meet regulatory standards and align with company policies.
• Oversee external vendors and manage documents in UCB systems to meet deadlines.
• Act as SME for patient-level data anonymization and privacy issues.
• Contribute to data sharing timelines and study/project commitments.
• Support SOPs, processes, and training for Data Transparency.
• Monitor regulatory environment and update Data Transparency policy as needed.

Conocimientos

Data transparency

Data anonymization

Regulatory compliance

Vendor management

Project management

Educación

Master's degree

Bachelor's degree

Descripción del empleo

Job Description

Make your mark for patients

We are looking for a Data Transparency Lead to join our Global Clinical Sciences and Operations team, based in our Raleigh, North Carolina office. This is a hybrid role (at least 40% of the time in office).

About the role

As the Data Transparency Lead, you will oversee global data transparency activities, ensuring compliance with transparency requirements and alignment with scientific and ethical standards. You will lead and support the preparation of data and documents for transparency, disclosure, and data sharing. The Data Transparency Lead will represent the organization as the transparency point of contact, both internally and externally, to provide input and guidance on related activities that represent industry best practices, including input on data elements that are useful and can be shared with statistical perspective (e.g., anonymization, data sharing, disclosure, etc.)

Who you'll work with

Develop and maintain efficient working relationships with contributing stakeholders (eg, Clinical Project Management, Biostatistics, Medical Writing, Regulatory Affairs,Safety, Information Technology). Interact frequently with the clinical development teams (Clinical Project Managers, Clinical Program Directors, and Biostatisticians) to ensure awareness of transparency requirements and the need for integration of planning to enable updated clinical trial protocol and results information availability within the mandated timeframes to meet transparency requirements. Support the Disclosure, Quality Control, Medical Writing Teams as needed.

What you'll do

• Prepare, lead, and support transparency documents and data anonymization activities, including plain language summaries, data sharing, redactions, anonymization, and regulatory submissions in compliance with Standard Operating Procedures (SOPs), FDA EMEA, ICH, and other relevant regulations.
• Collaborate closely with team members and 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 checklist and provide quality control (QC) of vendor activities to ensure quality and consistency.
• SME for patient-level data anonymization and privacy-related issues and identify process improvements and solutions with the ability to explain complex and technical topics to key internal stakeholders.
• Contributes to and manages data anonymization and data sharing timelines and commitments to timelines for the study and/or project.
• Provide support and input into the development of SOPs, processes, and training to support Data Transparency.
• Oversee project teams to ensure adherence to UCB's established Data Transparency Policy
• and SOPs.
• Monitor the external landscape and regulatory environment to identify and support updates that may be needed to UCB's Data Transparency policy.

Interested? For this role we're looking for the following

Minimum requirements

• 5+ (with Master's degree) or 7+ (with Bachelor's degree) years area of discipline (data disclosure and transparency roles) within Pharma or Biotechnology (including clinical research organizations) with specialized knowledge in patient-level data anonymization.

Preferred requirements

• Advanced experience in clinical studies design and analysis, including drug development phases, efficacy and safety assessments. In-depth knowledge of global disclosure, transparency, and data sharing.
• Excellent written and verbal communication skills and ability to communicate complex quantitative ideas clearly. Extensive experience in communicating with all levels of personnel across various departments in domestic and international environments.
• Ability to build relationships, establish trust and be a team player.
• Demonstrated experience in leading and participating in collaborative work teams at local and global levels.
• Advanced understanding of regulatory submission requirements for new product development and support.
• Good project management skills with attention to detail, including experience in leading meetings and managing multiple tasks concurrently.
• Ability to work under pressure and without close supervision.
• Vendor management experience
• Ability to travel both, domestically and internationally, as business necessitates
• Able to adapt to change and work in a multicultural global environment.
• Ability to work independently and explain complex topics to build consensus.
• Advanced level of analytical ability, exhibiting characteristics that are structured and methodical to ensure that sound decisions are made.
• Able to plan, perform, trouble-shoot and make decisions based on precedent, company policies, UCB procedures, national and international regulations, and Good Clinical Practice.
• Considerable judgement skills to work accurately and efficiently toward quality results, and to create new processes and procedures when necessary.
• Proactive in evaluating study and project reports to detect problematic issues.

This position reasonably anticipated base salary range is $148,000-194,000K. The actual salary offered will take into account related knowledge, skills, experience and location among other factors and may fall outside the expected range.

About us

UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are over 9.000 people in all four corners of the globe, inspired by patients and driven by science.

Why work with us?

At UCB, we don't just complete tasks, we create value. We aren't afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equal opportunities to do their best work. We 'go beyond' to create value for our patients, and always with a human focus, whether that's on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.

At UCB, we've embraced a hybrid-first approach to work, bringing teams together in local hubs to foster collaborative curiosity. Unless explicitly stated in the description or precluded by the nature of the position, roles are hybrid with 40% of your time spent in the office.

UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable federal, state, or local law. UCB invites you to voluntarily self-identify during the application process. Provision of self-identification information is entirely voluntary and a decision to provide or not provide such information will not have any effect on your application for employment, your employment with UCB, or otherwise subject you to any adverse treatment. Any information you provide will be considered confidential and will be kept separate from your application and/or personnel file and will only be used in accordance with applicable laws, orders, and regulations.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on [e-mail] for application to US based roles. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.