Medical Operations Lead - NEW at Abbvie

Key Responsibilities

• →Provides strategic leadership in study operations, fostering strong internal and external partnerships to drive and execute innovative ideas across all therapy areas
• →Acts as an Affiliate Subject Matter Expert in clinical research and study management, collaborating with key stakeholders to deliver Real World Evidence projects that address research gaps
• →Oversees resource allocation, vendor relationships, and financial management for research and publications, while continually enhancing user experience and operational efficiency through feedback-driven improvements
• →Responsible for supervising SOP and TMF management, archiving, CRO vendor assessment, and tracking Pre-Approval Access programs
• →Partner with affiliate Medical Teams to project manage study documents and execute clinical research projects
• →Collaborate cross-functionally to translate evidence gaps into Real World Evidence projects from setup to publication
• →Manage and develop a team, aligning activities with medical priorities and providing training and support
• →Allocate resources and oversee workload planning based on team needs
• →Supervise development, implementation, and follow-up of affiliate clinical studies and academic partnerships
• →Ensure quality control by defining, monitoring, and reporting on key quality indicators and driving continuous improvements
• →Provide operational input on protocol design, eCRF, and statistical analysis, and support feasibility and ethics submissions
• →Oversee data management, vendor relationships, compliance, study tracking, and deliverables reporting
• →Manage study budgets, contracts, drug shipments, and ensure on-time, on-budget delivery through negotiation and process development
• →Lead implementation and monitoring of early and compassionate access programs, ensuring compliance with regulations and timely protocol reviews