Associate Director, Clinical Documentation

Biopharma Careers; Warszawa; Hybrid; PLN 313,000 - 521,000; Full time

Benefits offered by this job

Annual bonus

Life insurance and pension plan

Private medical package

Company car or car allowance

Long‑term incentives

Sports cards (Multisport)

Job summary

GSK is seeking a senior TMF and Clinical Documentation Operations leader to drive global TMF strategy, governance, and transformation initiatives. You will guide AI integration, digitization, and real-time inspection readiness, while leading cross‑functional teams across development operations.

You will shape the TMF Reference Model governance, oversee sponsor frameworks, and support TMF activities for M&A and divestments, ensuring quality and compliance across global trials.

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.

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.

Skills

Agile Thinking

Communication

Data Analysis

Strategic Thinking

Problem Solving

Education

Bachelor's degree in life sciences or related field

Tools

Veeva eTMF

Documentum

SharePoint

Job description

For candidates seeking to be located at our Stevenage site, this role will temporarily be based at Stevenage. However, the Company plans to relocate its offices to Cambridge, UK. The location of this role will therefore subsequently change to Cambridge, UK in accordance with timelines to be set by the Company. The relocation is currently proposed to take effect by early 2029.

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.

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.

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 Processes

Salary Range

Polish Salary Range / Polski przedział wynagrodzenia: PLN 312,750 to PLN 521,250

Belgium Salary Range / Fourchette salariale – Belgique: EUR 81,000 to EUR 135,000

The 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 przedział wynagrodzenia zasadniczego brutto dla nowo zatrudnionych osób na tym stanowisku został wskazany powyżej dla każdej właściwej lokalizacji. Przedziały te uwzględniają szereg czynników, w tym umiejętności kandydata, doświadczenie, poziom wykształcenia oraz rynkowy poziom wynagrodzenia dla tego stanowiska W zależności od stanowiska i obowiązujących polityk wewnętrznych, rola ta może również uprawniać do otrzymania premii