Director, Clinical Documentation Operations, Open to flexible working
Global Clinical Operations is transforming to fulfil our vision to "Be the best performing and trusted Global Clinical Operations organization". Our mission is to "Accelerate the pipeline through innovative, efficient and expeditious delivery of high-quality data".
As the Director, Clinical Documentation Operations, you will be responsible for:
- Ensuring sustainable model is in place to build Clinical Documentation capability in the organization that meets regulatory needs for every clinical trial conducted in GSK
- Accountability for the business process and associated written standards and training strategy across Clinical Operations and other stakeholders that contribute to the generation and storage of Clinical Documentation
- Ensuring that the Veeva TMF Reference Model and the associated zone content is aligned with current and future thinking, internally and externally. Engage with a network of Zone Leads to drive best practices in utility and currency of the model across the end-to-end clinical development process
- Driving the embedding and implementation of Clinical Documentation process & systems across R&D
- Partnering with Clinical Quality Assurance to create and operationalise a Clinical Documentation Inspection Readiness Support team that guides study teams preparing for regulatory inspections
- Working with all relevant stakeholders to ensure a clear understanding of the challenges and associated solutions to ensure excellence in inspection readiness on a day-to-day basis
- Using key performance indicators to monitor performance of adoption and implementation of the Clinical Documentation systems and associated process. Create new and/or revise existing strategies to ensure 100% compliance for all studies.
- Serving as an expert point of contact for Clinical Documentation, both internally and externally, and in doing so be effective in influencing and engaging across multiple lines and regions.
- Driving Clinical Documentation strategies with external collaborators such as TransCelerate and others in the clinical document management arena
- Line managing, coaching and developing both on-shore and off-shore team members as required in support of the above.
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's degree in scientific discipline
- Scientific/pharmaceutical/vaccines industry background in research and development
- Detailed knowledge of drug/vaccines development and clinical processes.
- Expertise in information/clinical documentation management including: Trial Master Files, records retention, archiving, International Conference on Harmonization/Good Clinical Practice regulations for managing clinical documentation and Trial Master Files, use of technologies such as Documentum and SharePoint for information management, industry standards for clinical information management.
- Experience in delivering and embedding new ways of working
- Experience in leading and effecting significant change, innovation and results in multiple major processes/projects/systems /policies which span multiple functional/specialist areas
If you have the following characteristics, it would be a plus:
- Masters' degree or doctorate in Scientific, Quality or Risk Management discipline
- Demonstrated track record in leading and effecting significant change, innovation and results in multiple major processes/projects/systems /policies which span multiple functional/specialist areas
- Ability to influence strategy, to anticipate and analyze complex and ill-defined business problems/opportunities and a track record of developing and delivering high quality solutions that will have broad impact organizationally
- Ability to build a project plan & business case (including costings and timelines) and lead a large cross-functional team to deliver technical/business solutions
- Proven ability to clearly convey information orally and in writing (technical documentation, presentations to business stakeholders, etc.) to audiences with varied and sometimes limited technical knowledge
- Superior interpersonal skills, including the ability to establish and maintain good working relationships with peers, colleagues and management
- Ability to achieve work through others who do not report directly to them with guidance.
- Advanced ability to problem solve
- Ability to work independently and make decisions with minimal supervision
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk, governance and control, managing ambiguity and paradox.
- Managing individual performance.
- Creating a performance culture and driving results, prioritisation, execution, delivering performance.
- Setting strategic direction and leading on-going organisational transformation.
- Building a resilient organisation.
- Building strong relationships and collaboration in service of common goals, engaging the organisation and building trusted external networks for mutual benefit.
- Managing P&L and capital allocation.
If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.
Our goal is to be one of the world's most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.
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