Investigator Sponsored Study Delivery Lead
The Supported Studies Study Delivery Lead provides global operational support to the ISS and SCS process for all the Franchises/Therapy Areas within the Pharma Business Unit. This is a high visibility role with a global remit, that will offer the right individual a large presence both internally across multiple teams at GSK, and externally liaising with investigators from varying studies.
Responsibility and/or accountability for facilitating the set-up, coordination, execution and delivery of approximately 30 studies from one or more therapy areas, specifically:
Operational leadership of assigned ISS/SCS from concept to completion
• Proactively managing end to end study delivery for ISS and/or SCS, providing operational support for delivery of assigned studies ensuring they are conducted in accordance to GSK SOPs, relevant legislation, on time and within budget
• Working with the GSK supplies team/s to manage commercial and clinical supplies
• Working with the finance team/s to effectively forecast budget, track invoicing/payments and track actual spend
• Partnering with TPR to complete contracting activities such as due diligence and ABAC checks
• Study timeline and milestone management
• Manages end to end KPI reporting internally on study status
Operational point of contact for the external Sponsor of the study
• Interact and build strong relationships with external Sponsors/local operating company.
• Act as the point of contact for operational aspects of the study working together to overcome issues as required
• Facilitate engagement between Sponsor and GSK scientific and contracting teams as required
Operational point of contact for internal stakeholders
• Provide regular progress updates to key stakeholders and escalate issues as required
• Primary point of contact with GMALs, SS Coordinators and other key stakeholder groups including data management, safety, biostatistics, legal, compliance, project management.
• Lead and drive significant cross-therapeutic/functional business change initiatives according to company and/or group strategy and business needs. Be accountable for implementing new business processes and strategies.
• Scientific degree with experience in oncology, either in Medical Affairs/Clinical Operations or in oncology hospital (background in life sciences preferred).
• Oncology clinical experience very much desired
• Experience working in clinical research with investigators either in a hospital or cooperative group desired
• Demonstrated knowledge of protocol design in oncology studies.
• Thorough knowledge of FDA, ICH, GCP, and OIG guidelines.
• Understanding of cross-functional clinical processes including biostatistics, medical writing, drug safety, regulatory affairs, legal, clinical supply, medical affairs and scientific R&D.
• Strong planning and project management skills.
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