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. 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. Skills Agile Thinking, Business Process Improvements, CAPA Management, Change Management, Clinical Development, Communication, Data Analysis, Data-Driven Decision Making, Key Performance Indicators (KPI), Partnership Management, Problem Solving, Process Improvements, Resource Management, Strategic Thinking, Validation ProcessesPolish Salary Range / Polski przedzia wynagrodzenia: PLN 312,750 to PLN 521,250Belgium Salary Range / Fourchette salariale - Belgique: EUR 81,000 to EUR 135,000The annual gross base salary range for new hires in this position is listed above for each applicable location. These ranges take into account a number of factors including the candidate's skills, experience, education level and the market rate for the role. In addition, this position may offer an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. More detailed information on the total benefits package will be supplied during the recruitment process. This role is available for applicants from multiple locations, and therefore salary ranges for certain locations are also shown. Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process. Please note salaries vary by country based on the candidate's skills, experience, education level and the market rate for the role. Offers are typically made within the advertised range based on the candidate's skills, experience and qualifications, with the upper end generally reserved for highly experienced candidates or other exceptional circumstances aligned with these criteria.Roczny przedzia wynagrodzenia zasadniczego brutto dla nowo zatrudnionych osob na tym stanowisku zosta wskazany powyej dla kadej waciwej lokalizacji. Przedziay te uwzgldniaj szereg czynnikow, w tym umiejtnoci kandydata, dowiadczenie, poziom wyksztacenia oraz rynkowy poziom wynagrodzenia dla tego stanowiska W zalenoci od stanowiska i obowizujcych polityk wewntrznych, rola ta moe rownie uprawnia do otrzymania premii (jeli ma zastosowanie i jest przyznawana na podstawie okrelonych, obiektywnych kryteriow) oraz/lub nagrod za wyjtkowe wyniki (przyznawanych wedug uznania pracodawcy). Wszystkie wiadczenia ustawowe bd zapewnione zgodnie z przepisami prawa polskiego. Mog by take oferowane dodatkowe benefity, takie jak prywatna opieka medyczna, dodatkowe patne dni wolne, ubezpieczenie na ycie, prywatny plan emerytalny oraz w peni patny urlop rodzicielski i urlop na opiek nad czonkiem rodziny. Bardziej szczegoowe informacje na temat cakowitego pakietu wynagrodzenia i wiadcze przypisanego do tego stanowiska zostan przekazane podczas procesu rekrutacyjnego. Przedziay wynagrodzenia dla innych krajow mog by rownie widoczne, poniewa na niektorych rynkach obowizuj przepisy dotyczce jawnoci wynagrodze, ktore wymagaj zamieszczania takich informacji w ogoszeniach o prac, a wskazane lokalizacje mog stanowi potencjalne miejsce wykonywania tej roli. Jeli przedzia wynagrodzenia nie jest podany w ogoszeniu dla konkretnej lokalizacji lub kraju, odpowiednie informacje o wynagrodzeniu zostan omowione w trakcie procesu rekrutacyjnego. Prosimy pamita, e poziom wynagrodzenia roni si w zalenoci od kraju i jest ustalany na podstawie umiejtnoci, dowiadczenia, poziomu wyksztacenia oraz rynkowego poziomu wynagrodzenia dla danego stanowiska. Oferty s zazwyczaj przedstawiane w granicach wskazanego przedziau, z uwzgldnieniem umiejtnoci, dowiadczenia i kwalifikacji kandydata, przy czym gorna granica jest zwykle zarezerwowana dla kandydatow o bardzo duym dowiadczeniu lub w innych wyjtkowych okolicznocich zgodnych z tymi kryteriami. 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 View email address on click.appcast.io 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. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. 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