Internal Control Framework Excellence Manager, Open to flexible working
4 days left
- Contract Type
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"
As the Internal Control Framework (ICF) Excellence Manager you will work with Process Owners to design, implement and embed the Human Subject Research Internal Control Framework (ICF) across Clinical Operations and clinical partners in Development and in Vx and Rx R&D in collaboration with the R&D Quality organization.
In addition, you will contribute to the development, improvement & simplification of standards and processes across the clinical organization.
The responsibilities include but are not limited to the following:
- Work with assigned Process Owner(s) and a broad range of stakeholders to ensure the Clinical Operations processes are at the top of industry standards with respect to quality and efficiency.
- Use process intelligence data from internal sources (e.g. MM, IBM, IBAM, CAPA, Risk Management, end-user feedback, deviations) and external initiatives (e.g. TransCelerate, regulatory intelligence, Inspection CAPAs) etc. to identify and highlight drivers of change and recommend process improvements.
- Work with Process Owners to create plan for periodic review and update of relevant Written Standards.
- Support the implementation of the written standard framework for Human Subject Research and steer change management related to Standards and ensure the execution of operations
- Drive integration of assigned Rx and Vx processes where appropriate.
- Provide trends and other relevant reporting to Process Owners and Clinical Ops Leadership Team and help 'translate' trends to enable 'smart risk taking' and process improvement.
- Provide process expertise during technical qualification, mergers & collaborations
- Ensure that any findings from Audits, Independent Business Monitoring Assessments & Regulatory Inspections impacting Clinical Operations processes are analysed for root cause and that fit for purpose, realistic, clear, and timely CAPAs are defined and implemented.
- Bachelor's degree
- Knowledge of essential regulatory guidelines world-wide and GSK company policies and procedures e.g. detailed knowledge of GSK SOPs, ICH and FDA regulations as they impact all aspects of drug development
- A broad scientific/pharmaceutical/vaccines industry background in research and development
- Detailed knowledge of drug/vaccines development and clinical processes
As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.
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