The Country Clinical Operations Manager is the key leader for Clinical Operations at the country level for both internal & external partners. Accountable for the strategic and operational management for clinical operations and clinical site management activities for the assigned country/ies. Responsible for leading the implementation of the corporate vision and objectives, operating across all therapeutics areas to support the execution of AbbVie's pipeline. The role is accountable for country clinical trial performance, providing strategic planning, oversight and direction of the country team to ensure on time, within budget and quality delivery of internally conducted clinical studies. The Country COM is accountable to develop a highly collaborative framework with internal and external key stakeholders across the local and global organization to best position AbbVie in advancing clinical research and accelerating the transformation of science into best-in-class medicines.
•Defines the country strategy and operational plans aligned with AbbVie's business priorities, Clinical Development Operations and affiliate objectives in order to position the country for near and long term success.
•Continuously assess country site footprint across all therapeutic areas, expanding where there are opportunities and needs to support the pipeline.
•Provides leadership, strategic direction and oversight for all country activities across all stages of the clinical trial (country & site feasibility, selection and start-up, throughout study conduct and closure), ensuring high quality and scientific integrity of trial deliverables. Accountable for all Country level CDO deliverables for internally managed Clinical Studies.
•Provide leadership and oversight to the clinical research team including, but not limited to: * performing accompanied visits (on-site and off-site) * accelerate AbbVie's priority programs through close collaboration with internal and external stakeholders *conduct trend analysis and gap assessments to proactively identify training and developmental opportunities for assigned personnel * drive performance and address gaps to ensure the team achieves country and site level KPIs, KRIs & metrics
•Partners with internal stakeholders to drive insightful and impactful interactions and promote the value of the clinical research team through the contribution to the R&D portfolio success. Partners with GMA Medical Affairs Head to co-Lead the 'One R&D' collaboration within the affiliate. Operates as 'CDO Head' to support and represent non-CSM CDO personnel based within the affiliate.
•Accountable for the identification of resource needs, management of the allocated resources and timely hiring of clinical research staff to support clinical trials execution. Responsible for maintaining team capacity aligned with organizational needs, applying flexible and effective approaches for responsibilities assignment, that promotes staff development and retention.
•Defines and implements the optimal team organizational structure to support the needs of the business which allows the team to operate in a matrix and evolving environment, ensuring effective collaboration with key capabilities and roles. Identifies and implements strategies and tactics to ensure continuous efficiency, effectiveness and productivity of the country. Responsible for building a high performing team, accountable for the operational excellence in the execution of clinical trials.
•Accountable for ensuring adherence to applicable global and local regulations, ICH Guidelines and AbbVie Quality Management System, promoting a quality driven local organization, oriented to continuous improvement and excellence. Accountable for country Intelligence and impact analysis of all significant changes affecting the conduct of clinical studies, and for implementing procedural adjustments and orientation to guarantee team preparedness, alignment and compliance, as needed.
•Ensures Inspection Readiness across all activities, through effective leadership and oversight, promoting quality-driven initiatives. Responsible for the development of a critical thinking organization, focused on gap assessment, risk identification and mitigation strategies. Acts as the country expert for audit and inspection related processes, and may also serve as the local AbbVie host for in-country inspections/audits.
•Accountable for functional budget planning and management, ensuring accurate budgets and forecasts. Works closely with finance counterparts, guaranteeing seamless budget control processes and accurate communication of budget status, cost and issues to allow timely decision-making. Responsible for country feasibility, site selection strategy, and expanding AbbVie's site footprint within the country to support the pipeline.