DirecciónPosted Date: Mar 7 2024
Global Clinical Operations strives 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 Director, Regional Risk Management & Management Monitoring and local Country Operations Head to ensure that clinical research activities are conducted by local Clinical Operations staff in accordance to ICH GCP, relevant international and local 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.
Your Responsibilities:
This role gives YOU the opportunity to lead key activities to progress YOUR career, the main of these are:
- Lead all local Clinical Operations quality-related topics to ensure that clinical research activities are conducted according to ICH GCP, local regulations and GSK written standards.
- In collaboration with the local Country Operations Head, foster a quality culture and support delivery of upper quartile performance.
- Responsible for local risk management to ensure that all risks are properly managed, documented and escalated as appropriate within GSK.
- Support issue management activities, including issue identification, resolution and escalation across all studies and local Clinical Operations teams. Support resolution of critical/major issues.
- Involved in management monitoring efforts to ensure adequate controls for key risks, processes and business 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.
- Responsible to implement ongoing quality improvement processes, including those identified during management monitoring and issue management activities.
- Contribute to regional and/or global risks or issues for resolution/mitigation.
- 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 local Clinical Operations.
- Lead local initiatives to embed quality at investigator sites or hubs, while interfacing with key external stakeholders. Conduct site quality visits when needed.
- To act as the local ambassador for the global Quality, Capability and Risk Management organization.
- Share learnings and best practices across the country and with QCRMs in other countries/regions.
Why you?
Basic Qualifications:
We are looking for professionals with these characteristics to achieve our goals:
- Scientific degree: life sciences, medicine, clinical research, pharmacy or any related science degree.
- 3-5 years of experience in Clinical Operations. Advanced knowledge of the drug development processes and key operational interfaces.
- Extensive knowledge of ICH GCP requirements with strong knowledge of local and global regulatory requirements applying to clinical study delivery.
- Excellent written and verbal communication skills in English.
Preferred Experience:
However, if you have the following, it would be a plus:
- Master of Science or equivalent advanced degree.
- 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 regarding quality and governance.
- Knowledge of clinical written standards
If you feel this is your next career move, please apply up to March 17, 2024
Why GSK?
Our values and expectations are at the heart of everything we do and define our culture so that together we can deliver extraordinary impact for patients and consumers and make GSK a brilliant place to work.
As a GSK employee you will be encouraged to be you in a diverse and inclusive environment that focus on your wellbeing and enables you to feel good and to thrive, and gather the opportunities we offer to learn, develop and keep growing.
At GSK we believe that we all bring something unique and when we combine our knowledge, experiences and styles together, the impact is incredible. Join us to make the difference and play an important role on the benefit of millions of patients and consumers worldwide.
Why Us?
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 organization 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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