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- Partner with the GPL to expedite the management of clinical operational deliverables through application of integrated planning, best practices and project management capability.
- Work with study level leads to capture, track and manage cross-program risks and issues and implement appropriate mitigation strategies.
- Develop expertise on R&D and relevant TA governance processes and collaborate with clinical leaders and study managers to prepare deliverables required by associated stagegate and TA Review Board processes and deliverables.
- Build and maintain processes that will track and organize historical governance decisions and budget approvals as a resource to inform future governance planning efforts.
- Support the GPL and Clinical Team to assist in the management of late-stage program processes including LTE transition and program closeout activities.
- Partner with government and external partners to satisfy clinical objectives and advance the program as required.
- Develop new CTOL capability and assist in the collection and dissemination of best practices that can be leveraged across the portfolio.
- Support clinical teams by becoming a “trusted advisor” to project leadership and functional team members. Assist GPL in making informed and timely decisions by applying specific combination of relevant experience, project management expertise, and leadership capabilities to facilitate clinical program execution.
- Leverage expertise in project management tools and techniques, support the generation of project plans and provide insights based on customized project analysis and scenarios.
- Bring clarity and focus to key clinical activities through critical path analysis; work with PMO partners to ensure alignment and integration with CDT project plans in Planisware.
- Identify and communicate potential gaps in current cross-departmental processes and organizational structures and work with line management to remove obstacles to effective project execution.
- Proactively recommend and outline new processes for upcoming and current clinical development phases. Help integrate enabling technologies into the team setting to drive clarity and efficiency.
- Actively monitor and engage internal/external partners to ensure a constant awareness of emerging new practices, project management and leadership tools and strategies, and continuous improvement opportunities for CTOLs.
- Prior experience leading cross-functional global teams is required.
- Demonstrated ability to resolve conflict and influence teams without direct authority is required.
- Successful experience in planning and management of governance processes is required
- Good communication skills