This position is responsible for key tasks related to site management, territory development, and country study support. It plays a critical role in the local Global Clinical Trial Operations (GCTO) country management team and supports the country or cluster Clinical Research Director or Region Head in executing the Global Clinical Trial Operations strategy in the territory. The position will directly impact the country, cluster, or region's ability to reach business targets and objectives.Under the oversight of the Clinical Research Director or Region Head, the individual is responsible for monitoring resource management, capacity assessments of the Clinical Research Associate workload, and the overall quality of monitoring deliverables. The role has between three and twelve direct reports (Clinical Research Associate Managers) and indirect oversight of forty to one hundred fifty Clinical Research Associates.As a line manager, your role is critical in developing key talents in the organization to ensure a pool of success in critical roles. The individual is expected to ensure excellent study performance with strict adherence to local regulations, standard operating procedures, and International Council for Harmonisation Good Clinical Practice guidelines (ICH GCP). Additionally, the individual will collaborate at the local level internally with the Country Therapeutic Area director, Monitoring Excellence, Vendor Management, and can represent the Clinical Research Director in local management if required. Externally, the role involves collaboration with investigators, functional resourcing vendors, regulators, and the pharmaceutical industry.Responsibilities include, but are not limited to:Managing country or cluster monitoring resource management, conducting capacity assessments of Clinical Research Associate workload, and ensuring the overall quality of monitoring deliverables from the area across all projects and monitoring resources.Accountable for resource and talent management of the organization's Clinical Research Associates and Clinical Research Associate managers in the territory.Collaborating internally with Country Therapeutic Area Directors, Clinical Research Directors, Clinical Research Associate managers, Monitoring Excellence, Vendor Management, and Vendor Strategy to develop and build the territory of principal investigators and sites.Overseeing and managing local vendors and partners to ensure consistency across the country monitoring organization.Developing monitoring resourcing strategies in the country or cluster with vendors and Clinical Research Directors to meet current and future resource demands.Working with vendors to position and place Clinical Research Associates for optimal efficacy and effectiveness.Being accountable for the overall oversight of all Functional Service Provider Clinical Research Associates.Collaborating closely with other Global Clinical Trial Operations management roles, headquarters teams, quality compliance, finance, information technology, and human resources.Being a member of the local Leadership Team for Global Clinical Trial Operations and working closely with the country or cluster Leadership team, sponsors, and supporting strategic initiatives.This position and its direct reports significantly impact the ability to effectively conduct clinical studies and develop the pipeline while maintaining regulatory requirements and compliance. The individual will directly influence the country's ability to meet business targets and objectives while building productive collaborations with both internal and external business partners.Experience Requirements:A minimum of twelve years of experience within the pharmaceutical industry.A minimum of ten years of experience in clinical trial organization.A minimum of five years of experience in a functional management position.Advantageous:Experience as a Clinical Research Associate.Management of Clinical Research Associates and familiarity with outsourcing and flexible resourcing models.Educational Requirements:Bachelor's degree in science or equivalent healthcare experience. Advantageous: An advanced degree (for example, Doctor of Medicine, Doctor of Philosophy, Doctor of Pharmacy, Master of Science).This position is a regular employee status.
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