Supported Studies Delivery Lead Oncology

Job Description

Site Name: RTP, Upper Providence, Waltham, UK - London - BrentfordPosted Date: Aug 14 2020Supported Studies Delivery Lead - Oncology GSK House, UK or Upper Providence, Waltham, RTP US or Mississauga, CanadaThe Supported Studies Study Delivery Lead provides global operational support to the Investigator Sponsored Studies (ISS) and Supported Collaborative Studies (SCS) process for the Oncology Therapy Area 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, as you will be collaborating closely with investigators across a portfolio of studies. Responsibilities: Responsibility and/or accountability for facilitating the set-up, coordination, execution and delivery of approximately 30 studies in the Oncology TA, 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 contracting team to complete contracting activities such as due diligence and ABAC checks

Study timeline and milestone management

Manages end to end critical metric reporting internally on study status

Operational point of contact for the external Sponsor of the study

Interact and build positive 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 the need arises

Facilitate engagement between Sponsor and GSK scientific and contracting teams as the need arises

Operational point of contact for internal partners

Provide regular progress updates to key partners and raise issues as required

Primary point of contact with GMALs, SS Coordinators and other key partner 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

Proven knowledge of protocol design in oncology studies.

Detailed knowledge of FDA, EMA, 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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