Associate Director, Operations Oversight Lead Medical Affairs Research Global Operations (MARGO)

Overview

In this role, you oversee the end-to-end operations of observational studies within the MAR portfolio, ensuring timely, compliant execution across therapeutic areas. You collaborate with MAR scientists, Quality, Clinical Operations, Regulatory Affairs, and vendors to align study objectives and timelines. You actively identify and mitigate risks, manage vendor performance, and drive process improvements to support high-quality evidence generation. This position offers impact by shaping study execution in a global, regulated observational research environment. You will partner with leadership to optimize portfolio delivery and vendor strategy.

Responsibilities

• Oversee execution of observational studies across TA portfolios in collaboration with the MARGO Leadership Team
• Collaborate on strategic sourcing to optimize portfolio delivery
• Manage vendor performance, issue handling, and risk escalation
• Maintain vendor oversight plans with quality checks per oversight process
• Support initiation and execution of study vendor/service provider agreements
• Ensure alignment of study objectives and timelines with MAR scientific leads
• Own end-to-end study deliverables ensuring timely, high-quality completion
• Track milestones, timelines, deliverables, and financials with risk mitigation
• Coordinate resource utilization across programs to meet priorities
• Onboard study vendors/services to meet portfolio priorities
• Monitor compliance with process requirements, regulatory guidelines, and objectives
• Escalate quality/scope/timeliness issues to operational stakeholders
• Maintain regular communication with vendors and stakeholders to ensure delivery
• Identify opportunities for process improvement and standardization
• Collaborate with MAR oversight roles to drive best practices and consistency
• Coordinate with Quality for periodic quality reviews and issue escalation to QA

Key requirements

• Previous study operations or project management experience with operational and financial oversight of observational studies
• BS degree in Biology, Business, Operations Research or equivalent
• Hands-on training in managing study lifecycles in a GxP environment
• Experience leading cross-functional study teams and vendor resources in a matrixed setting
• Ability to communicate study scope, requirements, expectations, and standards for observational studies
• Proven vendor management experience including evaluating proposals, timelines, and budgets
• Experience with primary data collection and secondary data use studies
• Strong cross-functional collaboration across program, study, and vendor teams
• Knowledge of global NIS regulatory landscape and international study experience
• Ability to communicate study requirements/results effectively
• Strong data-driven problem-solving skills and robust written/verbal communication

• Cross-functional collaboration
• Strong communication
• Problem-solving with data-driven approach
• GxP compliance
• Vendor management
• Observational study lifecycle knowledge

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