[Alexion] Associate Director Country Operations Management

About the Company

Responsibilities

• ● Definition: Job Duties and Responsibilities
• ● Leading and developing of the dedicated functional group within Country Operations Management at local level.
• ● Ensures adequate resources for the studies assigned, ensure that workload of direct reports is optimized, and ensures appropriate and timely assignment to projects by liaising with relevant stakeholders (HCO, PMCO, global study team, etc).
• ● Development and performance management of direct reports, including implementation of development and training plan and regular coaching of the direct reports.
• ● Prepares salary and bonus proposals for direct reports based on their performance in close collaboration with responsible HCO
• ● Manages new staff interviews, hiring, onboarding process, for full-time and and in-sourced staff
• ● Ensures that study activities at country level comply with local policies and code of ethics, and ensures team delivery to committed activation and recruitment targets
• ● Contribute to Country feasibility analysis for new potential clinical trials (as applicable, depending on the direct reports the LM will be managing). Support the Country external scientific engagement strategy and action plan.
• ● Contribute to efficient COM organization and its functioning at country level by working closely with responsible HCO.
• ● Support HCO and in-Country COM activities as agreed with HCO, such as Site Oversight Visit reports review (as applicable, depending on the direct reports the LM will be managing) and onboarding and training of new in-Country COM functions and team members
• ● Act as extended local leadership team member with accountability to support the Country strategy implementation, champion the company values and suㅣpport HCO with the local affiliate and global DRS team cross-functional interactions required to support local COM goals.
• ● Contribute to the quality improvement of the study processes and other procedures through close partnership with DCQ at Country level
• ● Support inspection readiness activities at site and country level.
• ● Collaborates in identifying patient, site or country level quality deficiencies which may lead to the creation quality events/issues, and support in discussions around those as required (i.e: CAPAs). This may include to conduct Site Oversight Visits triggered by observed quality signals
• ● For individuals managing CRAs to:
• ● Plan and conduct regular accompanied/assessment visits with CRAs
• ● Provides support to their CRAs in managing site issues, from a monitoring perspective, ensuring that monitoring activities are conducted according to expectations.
• ● May act as a site liaison with prime sites for Alexion to facilitate discussion and consultation around site compliance to ICH GCP and process improvements, as agreed with their line manager.
• ● Collaborates with in-country local roles (PMCO and DCQ) in monitoring quality oversight based on agreed KPIs. Maintain tools to document and track clinical monitoring activities as required.
• ● If AD COM takes other role in combination to current responsibilities, please refer to the corresponding Job description.