Transparency Specialist Document Anonymisation

Position Summary
You will lead document anonymisation activities that support ethical and transparent sharing of clinical research data. You will work closely with cross-functional teams and external partners to prepare, anonymise, review and deliver clinical documents on time. We value curiosity, technical care, collaboration and a growth mindset. This role offers clear career development, meaningful impact on public trust in research, and alignment with GSK s mission of uniting science, technology and talent to get ahead of disease together. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Work closely with senior clinical data transparency leadership to align processes in line with regulations.

• Serve as a subject matter expert on regulatory requirements for document anonymization, including relevant agency policies and national guidance.

• Manage business relationships with external vendors to ensure quality, on time delivery and in line with organizational expectations.

• Manage daily operations of anonymizing clinical documents including regulatory requirements like EMA Policy 0070 and Health Canada PRCI ensuring quality and timelines targets are met

• Take overall accountability for the document anonymization capability, driving development, competence, and strategy internally and externally.

• Maintain strong relationships with internal business partners and act as a key contact supporting relevant functions for both current and historical studies.

• Create and lead a community of practice to improve cross communication between central functions, medical policy, and statistics/programming groups. Contribute to industry and regulatory standards for data re use and anonymization.

• Serve as the Business Capability Lead/Subject Matter Expert for document anonymization capabilities, including systems/technology and readiness for regulatory inspection/internal audit. Proactively propose process improvements based on feedback from clinical groups and governance bodies. Engage with teams authoring clinical documents to recommend working practices that minimize personally identifying information (PII) and commercially confidential information (CCI) in source documents.

• Ensure proper documentation and oversight of all business processes, standard procedures, and work instructions related to document anonymization, ensuring compliance with regulatory requirements.

• Monitor new technologies and external trends to ensure the capability leverages best in class approaches.

Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• Master s degree in life sciences, pharmacy, clinical research, or a related field.

• At least 6 - 9 years experience in document anonymisation, clinical trial transparency, or related regulatory work.

• Experience in Pharmaceutical company environment and specifically in matrix organization

• Experience in managing clinical trial (study, data, or system/technology) activities.

• Good understanding of clinical trial lifecycle, clinical trial metadata [i.e. information about the trials], clinical trial data [i.e. observed data collected as part of the trial], clinical documents.

Preferred Qualification
If you have the following characteristics, it would be a plus:

• Good understanding of RD and the clinical development process to enable understanding of anonymization related activities, manage risks and, where required, develop novel solutions and processes.

• Good overview and understanding of end to end study process and data flow; in-depth knowledge of patient data - a recognized expert.

• Ability to bridge the communications gap between scientific/medical and non-scientific organizations.

• Ability to communicate the importance of relevant technical or process solutions to business problems. Provide personalized communications with reasons and rationale, context and relevance of the thinking. Describe anonymization in a way that can be understood by the Business.

• Excellent verbal and written communication skills.

• Ability to work with a high degree of independence.

• Good teamwork and interpersonal skills with demonstrated ability to interact effectively across boundaries with other global functions using influencing and relationship building skills.

• Ability to effectively manage conflicting demands in a high pressure, constantly changing environment and still achieve timely delivery

• Awareness of medical writing, publishing and regulatory processes and associated deliverables.

• Experience of reviewing clinical documents is an advantage.

What success looks like
You deliver anonymised documents consistently and on time. You build strong working relationships with internal teams and vendors. You help improve anonymisation processes and support a culture of quality and transparency. You welcome feedback and use it to grow.