Manager, Clinical Documentation

**Site Name**: Warsaw, Belgium-Wavre
**Posted Date**: May 14 2025

**Manager, Clinical Documentation (12 month secondment/ replacement)**

This role is primarily accountable for implementation of elements of the strategic plan to meet GSK’s commitments and to focus the R&D organisation on consistent, readily accessible, inspection ready and available clinical documentation in the shape of a Trial Master File for every study.

Clinical Documentation manager plays a critical and matrix leadership role with all parts of the R&D organization that contribute documentation to the TMF and implement strategies that incorporate the many systems that hold TMF information.

Clinical Documentation manager is specifically accountable for implementing strategies that build organizational capability in a pan R&D new way of working that requires a significant shift from current practices and mindset to ensure GSK is in a strong position to deliver TMFs for all studies in a simple, consistent and sustainable way fully aligned with international regulatory expectations.

Areas of focus for this secondment include supporting TMF migration planning and execution in the Business Development space (Mergers, Acquisitions, & Divestments) and supporting initiatives towards optimizing and enhancing the usability of Veeva COV eTMF.

**_ Responsibilities:_**
- Plan and execute TMF migrations and support key TMF decisions within the Business Development space (Mergers & Acquisitions and Divestments)
- Lead/support projects aimed at improving Veeva COV eTMF system usability, efficiency, and compliance
- Support other various Clinical Documentation initiatives, where needed

**_ Why You? _**

**Qualifications**:

- Excellent working knowledge of International Conference on Harmonization/ Good Clinical Practice regulations and Corporate & R&D policies and Standard Operating Procedures for sponsor study records
- Broad knowledge of clinical documentation management and archiving technologies (e.g., Veeva eTMF, Documentum, SharePoint) and processes.
- In depth knowledge of Trial Master File Reference Model
- Able to build a project plan, with guidance, to deliver a technical/business solution
- Proven capability in delivering and embedding new ways of working
- Demonstrated ability to coordinate the work of others
- Proven ability to analyze business problems/opportunities
- Superior interpersonal skills, including the ability to establish and maintain good working relationships with peers, colleagues and management
- Proven record of being customer driven
- Proven ability to communicate and negotiate effectively with stakeholders at all levels across functional boundaries.
- Excellent written and oral communication

**_ Why GSK?_**

**What we offer**:

- Career at one of the leading global healthcare companies
- ** Contract of employment ( 12 months replacement contract)**
- Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit)
- Hybrid working model (where GSK site are in Poland)
- Extensive support of work life balance (flexible working solutions, min. **2-3 days/week working form the office**, short Fridays option, health & well-being activities)
- Life insurance and pension plan
- Private medical package with additional preventive healthcare services for employees and their eligible
- Sports cards (Multisport)
- Possibilities of development within the role and company’s structure
- Personalized learning approach (internal trainings, mentoring, access to online training’ platforms: Keep Growing Campus, LinkedIn Learning, Business Skills, Harvard Manage Mentor, Skillsoft and external training)
- Supportive community and integration events
- Modern office with creative rooms, fresh fruits every day

**#LI-GSK**

**#LI-HYBRID**

**Why GSK?**

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

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you s