Manager, Outsourced IRT
Site Name: UK - Hertfordshire - Ware, USA - Pennsylvania - Upper Providence
Posted Date: Oct 25 2019
We are seeking an Outsourced IRT Manager to join GSK. This role may be based in the US at our site in Collegeville, PA or in the UK at our site in Ware.
- Facilitate discussions on IRT design between GSK clinical supplies team and IRT vendor
- Ensure vendor IRT specification and service meet GSK clinical supply requirements for outsourced studies
- Review and approve clinical supply aspects of the IRT User Requirement Specification document for outsourced studies
- Co-ordinate GSK Clinical Interface acceptance of vendor IRT systems for outsourced studies.
- Support interaction between GSK study team, Clinical Interface supply team and IRT vendor during maintenance phase of outsourced studies.
- Participate and provide oversight as needed for system amendments post go Live
- Provide system and process knowledge for GSK systems that integrate with IRT system
- Participate as an active member on the Supply Strategy Blinding committee assessing outsourced studies.
- Maintain an ongoing list of outsourced IRT studies and TPS resource demand to support them.
- Develop, maintain and report appropriate outsourcing performance metrics including perform periodic resupply reviews of Stock-Outs/Near-Misses and implement appropriate improvements/resolutions.
- Continually assess internal and outsourced IRT ways of working to identify issues and implement process improvements for outsourced IRT studies
- Facilitate issue resolution between IRT vendor and GSK Clinical Interface Team
- As appropriate, write, participate, and lead Deviations/Customer Complaints and associated CAPAs.
- Support the FSO Team in the vendor assessment process by technically qualifying IRT vendor capabilities to meet GSK requirements.
- As needed, assist the FSO Team in updating the IRT section of the CRO Strategic Relationship Handbook
- Define strategic direction for IRT Outsourcing and management of studies and resources
- Contribute to the establishment and evaluation of outsourced IRT Governance processes
Why you? Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's Degree in life science, computer science, engineering, business or related discipline
- Minimum 7+ years of IRT experience and / or a clinical supply chain discipline (supply chain management, distribution, packaging, labeling, etc.)
- Experience inapharmaceutical industry or CRO environment
- Working knowledge of clinical trial systems
- Experience in reviewing and translating study protocols, translate the protocol to IRT specifications for development of fit for purpose systems
- Exposure to working in a GMP / GCP environment and with regulatory audit teams
- Demonstrated analytical skills and a working knowledge of Microsoft Office
- Comfortable working with a global team in a change agile environment
If you have the following characteristics, it would be a plus:
- Proven expertise in the proactive identification of issues impacting patient safety and the ability to contribute to solutions affecting cross-functional matrix teams.
- Excellent influencing and negotiation skills
- Vendor Management experience
- Experience in developing long term operational strategy for IRT
- Ability to present complex technical issues to non-technical people
Our values and expectationsare at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigor and risk.
- Managing individual and team performance.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Implementing change initiatives and leading change.
- Sustaining energy and well-being, building resilience in teams.
- Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
- Developing people and building a talent pipeline.
- Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
- Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
- Budgeting and forecasting, commercial and financial acumen.
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GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, 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.
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