Associate Director, Clinical Documentation

You will represent Clinical Documentation Operations (CDO) at GSK as part of a broader team, collectively responsible for defining and implementing our global TMF and clinical documentation strategy, governance, and standards. In this leadership role, you will bring deep TMF expertise to drive CDO priorities, elevate TMF process excellence and inspection readiness at enterprise scale, guide the responsible use of AI and other technologies, and partner cross-functionally and externally to support our transition toward a more data-focused TMF and clinical documentation environment.

We value clear communicators who solve problems, coordinate delivery, and focus on quality. This role offers visible impact, clear growth paths, and the opportunity to strengthen clinical systems that support patient-focused research.

Key Responsibilities:

• Help deliver GSK's global TMF and clinical documentation strategy, focusing on innovation, continuous improvement, and smooth day-to-day operations.

• Provide leadership for GCO record management and archiving by defining and maintaining the Function Data Map and archiving submitter guidance for Development Operations across GSK's approved archiving repositories.

• Shape and implement GSK's TMF transformation journey, including the AI roadmap and longer-term digitization and data capture strategies, to automate workflows at scale across clinical trial processes and ensure real-time inspection readiness.

• Lead TMF Reference Model governance, driving evaluation, approval, and implementation of changes, coordinating impact assessments with stakeholders, and preparing the organization for adoption of the new industry Standard Model v1.

• Serve as TMF subject matter expert for studies conducted under GSK's Full Service Outsourcing model, leading the TMF sponsor oversight framework and partnering with CRO TMF SMEs to ensure robust TMF quality and compliance.

• Lead and support TMF activities for mergers, acquisitions, and divestments, providing expert advice on TMF health assessments and driving successful TMF migration projects.

• Represent TMF in cross-functional governance and external industry forums, leading process improvements and championing quality and continuous improvement.

Why You?

Basic Qualifications:

• Bachelor's degree or equivalent in life sciences, clinical research, pharmacy, or a related field.

• Minimum 5 years' experience in clinical documentation, TMF management, or clinical operations.

• Proven track record in shaping TMF strategy, governance frameworks, or organization-level TMF operating models.

• Demonstrated ability to lead cross-functional teams without direct authority, with strong communication, influencing, and stakeholder management skills.

• Strong working knowledge of ICH Good Clinical Practice and clinical records management standards (e.g., CDISC TMF Reference Model, ALCOA+).

• Strong project coordination skills and ability to manage multiple priorities.

• Proficient in English.

Preferred Qualifications:

• Hands-on experience with Veeva eTMF, Documentum, SharePoint, or similar platforms.

• Experience implementing and maintaining a TMF Reference Model.

• Experience supporting TMF activities for mergers, acquisitions, divestments, and/or TMF migration projects.

• Experience working in a variety of outsourcing models, with direct responsibility for vendor management and oversight.

• Experience in data mining and analytics (e.g., using TMF/eTMF data, metrics, and dashboards) to identify trends, drive continuous improvement, and support inspection readiness.

• Experience leading enterprise-wide eTMF system implementations, migrations, or broader technology transformations, including AI/ML solutions within a GCP-regulated TMF or clinical documentation environment.

• Certification or formal training in clinical trial management, quality, or records management.

Working model:

Hybrid, based in a GSK R&D Hub location. You will be expected to work from the office regularly, with flexibility to work remotely.

Why GSK?

Benefits:

• Career at one of the leading global healthcare companies.

• Contract of employment.

• Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit).

• Life insurance and pension plan.

• Private medical package with additional preventive healthcare services for employees and their eligible counterparts.

• Company Car or Car Allowance.

• Long term incentives.

• Sports cards (Multisport).

• Possibilities of development within the role and company's structure.

• Personalized learning approach (mentoring, online training' platforms: Pluralsight, Business Skills, Harvard Manage Mentor, Skillsoft and external training).

• Extensive support of work life balance (flexible working solutions, short Fridays option, health & well-being activities).

• Supportive community and integration events.

• Modern office with creative rooms, fresh fruits everyday.

• Free car and bike parking, locker rooms and showers.

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Skills

As an Inclusive employer, we encourage you to reach out if you need any adjustments during the recruitment process. Please contact our Recruitment Team at pl.recruitment-adjustments@gsk.com to discuss your needs.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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