Head of Study Management
The Head of Study Management (HSM) is accountable for execution and delivery of all studies assigned to the LOC across therapy areas to time, budget and quality as defined in the study protocol as well as in local regulations, ICH GCP / IND guidelines, and GSK written standards.
The HSM serves as a point-of-contact for cross TA and cross study issues with relevant central study teams and key stakeholders.
• Role requires working in a highly matrixed environment with internal and external customers both regionally and globally based. Customer service is a focus, as role requires interaction with other GSK business areas and external stakeholders, investigators and site staff. Adaptability is crucial as clinical development plans and implementation needs are continuously evolving. Must manage diverse study and/or program teams.
• Provide oversight of the conduct of studies and/or programs to ensure compliance with internal & industry policies and regulations; managing areas of risk by developing local study and site level risk assessment and supporting the LSM / LSSMs in the development of mitigation plans
• Proactively track timelines and identify issues in order to propose strategies to implement contingencies and risk planning to meet overall study/program goal
• Accountable to ensure all studies assigned to the LOC are delivered to quality and agreed budget within the required timelines.
• Responsible to work with the Local Study Managers (LSM) to resolve and escalate issues that may impact study delivery.
• Responsible for leading the team of LSMs by providing training, coaching and mentoring including line and performance management.
• Responsible for standardizing processes, identifying and sharing best practices and representing local study management on internal and cross functional process improvement teams.
• Responsible for effective resource utilization so that studies are resourced appropriately.
• Bachelor's degree in general science e.g. life science, medicine, clinical research degree, pharmacy etc.
• Solid understanding of R&D and drug development process
• 7+ years of clinical research experience with a minimum 5 years of clinical study management
• Experience across a range of Phase I - IV studies.
• Masters of Science in general science e.g. life science, medicine, clinical research degree, pharmacy etc.
• Previous oncology experience
• Collaborative and open leadership style. Adapts management style to different situations independently and as appropriate.
• Individuals in this role bring clinical expertise and are involved in the training of staff in the Study Manager role.
• Strong written and verbal communication skills.
• Strong negotiation skills.
• Experience in contributing to key process initiatives for operational strategies
• Solid understanding of clinical practices and oncology areas.
• Demonstrated ability to manage clinical study resources and activities including multiple products or indications.
• Demonstrated capability in clinical study conduct processes.
• Demonstrated project management and team management skills.
• Demonstrated ability to implement change.
• Demonstrated line and/or matrix management skills.
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