Senior Director, Head Clinical Documentation

il y a 3 semaines

Wavre, Belgique GSK Temps plein

**Site Name**: Belgium-Wavre, GSK House, Stevenage, USA - Pennsylvania - Upper Providence, Warsaw

**Posted Date**: Jul 21 2023

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.
- 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 pe

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