IRT SME & Outsourcing Lead

Basic qualifications:

The individual interacts with GSK Clinical Study teams including Clinical Operations, Statistics, Clinical Outsourcing, TPS Clinical Interface and CROs providing IRT services to ensure GSK discharges its accountability around IRT design and execution. The individual will assure that any vendor IRT is fit-for-purpose to support GSK's outsourced clinical studies and consistent with expectations of internal IRT provision.

Qualified individuals should possess a minimum knowledge of following:

  • Understanding of the medicines development process and IMP supply
  • Demonstrates detailed knowledge of IRTs and integrated supply chain computer systems.
  • Detailed knowledge and experience of IRT study design, configuration and maintenance
  • Previous working experience with complex clinical information systems such as IRT, Clinical Trial Management Systems (CTMS), and Electronic Data Capture (EDC) systems
  • Ability to maintain accurate records and files in accordance with GSK policy, GMP/GCPs, and SOPs
  • Demonstrated knowledge and experience of various software: Excel, Word, Powerpoint, Visio, MS Project, Visio, etc.
  • Proven ability to work in a matrix team
  • Ability to work independently
  • Ability to lead projects and key stakeholder interactions
  • Should be detail-oriented and possess the ability to handle multiple tasks
  • Ability to train others inside and outside the workgroup in area of expertise
  • Experience in working with customer relations
  • Must exhibit excellent oral and written communication skills
  • Good interpersonal skills
  • Good planning and coordination skills
  • Creative and innovative thinking
  • Strong problem solving skills
  • Drive/implement continuous improvements
  • Analyze and report data

Preferred qualifications:

Key Results (Principal Accountabilities):

Is accountable as the primary IRT expert for outsourced clinical studies and will support study teams, outsourcing and Quality groups in assessment of vendors

Collaborating with study teams, clinical operations, supply chain leads and IRT vendor to facilitate quality IRT system consistent with protocol design and GSK expectations

Will assure that vendors meet GSK's requirements of utilizing appropriate blinding and supply strategies, consistent with the expectations of internal IRT provision.

Develop and maintain GSK IRT processes and standards with vendors

Participate in the selection of IRT vendors, including review of competitive bids and potential vendor audits

Benchmark external IRT vendor's and systems against GSK's internal IRT performance and capabilities

Contribute in

Define strategy and roadmap for development and operations of the RAMOS NG system with the vendor and participate in Governance meetings

Provide support for upgrading RAMOS NG

Specific Activities:

1.Obtain VOC of GSK Clinical and address issues and implement process improvements for outsourced IRT studies.

2.Collaborate closely with IT to ensure the business needs for the proposed IRT solutions are fully understood

3.Ensure vendor IRT specification and service is suitable for GSK studies including: the study-specific User Requirement Specifications, IRT design and End User training materials

4.Review and pre-approve vendor test plans/scripts before they are executed by the CRO/vendor. Review/approve final test plan reports.

5.Will co-ordinate GSK acceptance of vendor IRT systems for outsourced studies

6.Support interaction between GSK study team, Clinical Interface supply team and vendor during design and maintenance phases of outsourced studies.

7.Review and revise training documents and investigator slides

8.Act as liaison between various customer groups to ensure timelines are met

9.Participate and provide oversight for protocol/system amendments post go Live and ensuring approval from all study stakeholders

10.Facilitate randomization and container code information between GSK and vendor

11.Provide system and process knowledge for GSK systems that integrate with IRT system

12.Participate as an active member on the Supply Strategy Blinding committee assessing outsourced studies.

13.Maintain an ongoing list of outsourced IRT studies and TPS resource demand to support them.

14.Develop, maintain and report appropriate outsourcing performance metrics including perform periodic resupply reviews of Stock-Outs/Near-Misses and implement appropriate improvements/resolutions.

15.Perform AARs of implementation of IRT for outsourced studies to obtain learnings and drive continuous improvements for GSK outsourced IRT studies.

16.Write, participate, and lead Deviations/Customer Complaints and associated CAPAs.

17.Understand system functionalities, including capabilities and limitations, for GSK's internal IRT system

Details:

The individual interacts with GSK Clinical Study teams including Clinical Operations, Statistics, Clinical Outsourcing, TPS Clinical Interface and CROs providing IRT services to ensure GSK discharges its accountability around IRT design and execution. The individual will assure that any vendor IRT is fit-for-purpose to support GSK's outsourced clinical studies and consistent with expectations of internal IRT provision.

  • LI GSK*

Contact information:

You may apply for this position online by selecting the Apply now button.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).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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