Posted Date: Jul 21 2023
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GSK is a place where outstanding people do amazing things. As a science-led global healthcare company, we exist to help people do more, feel better, live longer. Our goal is to be one of the most innovative, best performing, and trusted healthcare companies.
Are you a seasoned Clinical Operations or Document Management leader with the energy and passion to develop and execute appropriate strategies to steer our company in maintaining a best-in-class Trial Master File (TMF) infrastructure? Are you sensitive to the needs of your stakeholders and is collaboration more than just a word to you? Are you someone who sees the vast abilities that your team has and is passionate about developing your team members so that we can continue to deliver on our vision, goals, and strategies?
With the Head Clinical Documentation for GSK Global Clinical Operations (GCO), we offer the opportunity of an impactful and highly visible leadership role whose purpose it is to develop and deliver a best-in-class TMF environment that leads to inspection-ready TMFs in all of our clinical trials.
Key Responsibilities:
Developing and implementing the vision, goals and strategies for providing a best-in-class TMF environment
Developing, implementing and continuously improving the end-to-end TMF process from account management, set-up, management, QC oversight, closure to archiving
Developing, implementing and continuously improving the eTMF system and ensuring modernization as needed
Developing and maintaining measures to monitor TMF process and system performance as well as TMF compliance across the clinical trial portfolio
Building partnerships, leading and driving change, influencing mindset and culture to enhance organizational performance in regards to TMF usage and compliance
Ensuring appropriate inspection preparation and inspection support for all matters TMF
Serving as an expert point of contact for TMF, both internally and externally, successfully influencing and engaging internal and external stakeholders to shape the TMF space within GSK and the industry
In addition to TMF, the Head Clinical Documentation is also accountable for:
Overseeing and driving the controlled transfer of unstructured documents and data (i.e. documents and data not stored in structured and controlled databases) for acquisitions and divestments
Overseeing and driving the provision of operational clinical trial data from CTMS for select purposes supporting internal decision making and regulatory reporting
Leading, managing, coaching and developing a team of approximately 25 associates located in Europe, US and India
As a member of the QCRM leadership team, co-driving and co-developing the quality & compliance agenda for GCO together with the QCRM LT peers and under the leadership of the Head of QCRM.
Basic Qualifications
Bachelor’s degree in Life Sciences, or equivalent
Very strong expertise in Clinical Operations, preferably including prior leadership experience in a support function, or very strong expertise in Document Management (any area)
Significant prior team leadership experience
Able to think outcome- and impact-focused
Able to see the big picture, to develop a guiding vision and define clear goals and strategies in support of that vision
Able to translate a strategy into actionable items and follow-through with execution until full delivery of the desired impact
Able to communicate clearly and to the point with the flexibility to adjust based on the audience and desired impact
Be at ease with partnering with senior and junior stakeholders across the organization (inside and outside of GCO) and with partners and service providers external to GSK
Able to truly collaborate, i.e. to listen, understand, align and deliver as a team with diverse stakeholders and team members
Understand the difference between leading and managing, be strong at both and know when you are required to be a leader and when a manager
Preferred Qualifications
Masters Degree
Business Acumen - understands implications of decisions from a broad business perspective and uses this knowledge to influence decision-making at the highest levels of R&D and with external partners.
Proven ability to drive process improvement in a matrix environment and with demonstrated leadership in the application of innovative approaches with portfolio-level impact.
A strong sense of initiative, urgency, drive, pragmatism, and judgement – an ability to make things happen.
Ability to deliver to demanding deadlines whilst maintaining the highest quality.
- LI-GSK
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.
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. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.
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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
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