Posted Date: May 17 2023
Locations: ability to sit in any of these countries - Canada, United States, Mexico, Panama, Brazil, or Argentina
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”.
The successful candidate will work with the Directors, Risk Management (Global Clinical Delivery (GCD) and Data Strategy & Management (DS&M)) to ensure that clinical study delivery activities are conducted by central Global Clinical Operations staff in accordance to ICH GCP, relevant international regulations, requirements and guidelines, as well as GSK written standards. This enables the delivery of clinical studies with quality data and supporting upper quartile performance objectives.
- Support Global Clinical Operations quality-related topics to ensure that clinical study delivery is conducted according to ICH GCP, and GSK written standards by central functions – i.e., Global Clinical Delivery (GCD) and Data Strategy & Management (DS&M)
- In collaboration with the Directors, Risk Management, support the development and maintenance of functional documentation (Risk Register, Management Monitoring and Training Plan) to ensure that:: All risks are properly managed, documented and escalated as appropriate within GSK, and all aspects of management monitoring (MM) activities are delivered, including identification and delivery of MM-related CAPAs
- Support issue management activities, including issue identification, resolution and escalation across all studies and GCD/DS&M teams. Support resolution of Significant Quality Issues (SQIs).
- Share learnings and best practices across GCD/DS&M and across Global Clinical Operations as a whole.
- Responsible to implement ongoing quality improvement processes, including those identified during management monitoring and issue management activities.
- Responsible for supporting internal assessments and regulatory inspections, in close partnership with Clinical Quality Assurance (CQA). Will also ensure completion of regulatory CAPAs on time.
- Foster a quality culture and support delivery of upper quartile performance.
- Contribute to GCO meetings to present on quality-related topics, including but not limited to the following: Global Clinical Delivery Leadership Team (LT) meetings, Global Clinical Operations forums, SDL/SDS engagement sessions, Study team meetings and Quality forums
- In collaboration with the Capability Building team, support the global capability and training activities related to the conduct of clinical research and to meet the changing regulatory environment and updates to GSK written standards
- Maintain an external focus, via industry consortia, industry networks and country/regional regulatory forums to identify emerging trends in quality and compliance which may impact GCD/DS&M
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- Bachelor of Science degree
- 5+ years’ experience in Clinical Operations in a study-facing role
- Experience with the drug development processes and key operational interfaces
- Experience with ICH GCP requirements and with global regulatory requirements applying to clinical study delivery
Preferred Qualifications
If you have the following characteristics, it would be a plus:
- Master of Science or equivalent. Advanced degree preferred but not essential.
- Previous experience in quality management
- High degree of organizational awareness; good understanding of clinical/corporate governance principles and demonstrated ability to develop solutions to complex problems with regard to quality and governance
- Knowledge of clinical written standards and experience in delivering clinical research training
- Proven negotiation skills
Why GSK?
#LI-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 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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