Job description Posted 02 October 2020

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.

Job Requirements:

• 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.

Additional information about the process

Why GSK?

At GSK, we're a company with a special purpose, to help people do more feel better and live longer. Realising our purpose starts with us. When we feel at our best, we perform at our best.

When you set out on your adventure at GSK, we make a deal. You commit to living GSK's values and expectations and performing against our Innovation, Performance and Trust priorities. And in return, GSK commits to providing the right environment for you to thrive. Put simply, it’s about you being motivated to do your best work, in a place where you can be you, feel good and keep growing.

Together we build an environment where we can all thrive and focus on what matters most to each of us. It is only through the energy, dedication, drive and passion of all of us that we can be the very best for GSK, and importantly, for our patients and consumers.