Study Delivery Lead

il y a 4 semaines

Wavre, Belgique GSK Temps plein

**Site Name**: Belgium-Wavre

**Posted Date**: May 5 2023

Are you a clinical operations professional looking for an exciting and varied role in a dynamic, high performing department? Are you currently in a scientific role but looking for a new challenge? This could be the job for you

**The Role**:
This Study Delivery Lead role within VEO Study Delivery and Quality Operations involves the end-to-end design, execution, and reporting of clinical studies.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following
- Planning and leading the delivery of VEO studies to timelines, quality, budget, company standards and scientific requirements; from concept protocol to final study reports.
- Accountable for coordination and delivery of a fully feasible Study Protocol, Informed Consent Forms, operationally robust study documents and Clinical Study Reports.
- Accountable for the study delivery strategy (e.g. country selection, diversity, patient identification and engagement strategy, recruitment plan, digital platforms/tools etc)
- With the majority of VEO studies fully outsourced this role includes responsibility and/or accountability to drive assessment, selection, engagement, and management of appropriate vendors.
- Ensure compliance with ICH/GCP & ENCePP guidelines and/or applicable guidelines for VEO studies such as Good Pharmacovigilance Practices (GVP), Good Epidemiological Practices (GEP) and CIOMS, all applicable laws and regulations, and GSK SOPs, for all products and services delivered for their designated studies.
- Make decisions which balance risk/benefit with clear understanding of impact on the study and project; acts to mitigate risk where appropriate.
- Work with matrix partners, Study Delivery Therapy Area Lead and/or manager to develop and manage study level budget within project budget allocation.
- Requires active partnership building for their portfolios and collaboration with therapy aligned staff in other functions. Interact effectively across boundaries with other global functions using influencing and relationship-building skills.

**_ Why you?_**

**Basic Qualifications**:
We are looking for professionals with these required skills to achieve our goals:

- Bachelor’s degree in life sciences or related discipline
- Broad understanding of the pharmaceutical industry and the clinical development process
- Ability to establish and build internal and external relationships at all levels in a highly dynamic matrix environment
- Highly developed communication skills appropriate to the target audience, promoting effective decision-making where necessary
- Ability to work independently and proactively and to take on leadership roles on cross-functional study teams
- Excellent leadership skills
- Excellent influencing and negotiation skills

**Preferred Qualifications**:
If you have the following characteristics, it would be a plus:

- In depth knowledge of study management and knowledge of essential regulatory guidelines worldwide
- Proven expertise in the proactive identification of issues which may impact clinical programmes coupled with the ability to contribute to solutions affecting cross-functional matrix teams
- Advanced degree (e.g. MS, PhD, PharmD) or equivalent experience
- Demonstrated experience leading in a matrix environment to deliver projects, develop clinical plans, and manage change
- Experience in managing relationships with vendors to ensure successful delivery of projects

**_ Why GSK?_**:
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 impact the health of 2.5 billion people around the world in the next 10 years.

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 share our ambition, join us at this exciting moment in our journey to get Ahead Together.
- Li-GSK

VaccinesRD

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

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