Clinical Study Manager
Up to £395 per day via umbrella
This exciting role is working at GSK on in-house or outsourced HIV studies with a key asset(s) for ViiV Healthcare within the Central Study Team (CST). Candidates will be excellent team players, able to work at a fast pace within a complex matrix environment and have the ability to manage multiple stakeholders with a focus on quality and upper quartile operational delivery. Candidates should have at least 5 years’ experience in a similar position with HIV and outsourcing experience preferred. To align with the GSK expectations candidates should demonstrate excellent leadership skills, flexibility to work with global matrix teams across different time zones, be able to take accountability for assigned deliverables and have a positive approach to new systems and processes.
Activities may include (but not limited to) the following:
· Accountable to ensure all relevant studies follow GSK SOPs and GCP.
· Maintain relationships and monitor performance of CROs and other vendors.
· Effective collaboration with ViiV and the GSK Clinical Operations functional groups (e.g. Regional Monitoring, Data Management, stats, clinical supplies) to ensure high quality data
· Work closely with the LOCs and address any study related questions and issues.
· Manage sites/countries transitioning from study to commercial supplies.
· Manage study budgets.
· Provide oversight and ensure quality of the study eTMF.
· Identify risks and issues and escalate as appropriate.
· Oversee and track study milestones.
· Study start-up conduct and close-out activities.
· Provide input into investigator and monitor meetings.
· Senior stakeholder management at GSK and ViiV.