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Medical operations lead - new

Maidenhead
Posted: 12 December
Offer description

Job Description Office based in Maidenhead (hybrid working model 3 days in office) Reporting to the Head of Medical Operations Newly created leadership role at AbbVie UK: excellent compensation and benefits package, with great opportunities to develop your career Job Overview The Medical Operations Lead will provide leadership and oversight, to ensure medical projects are delivered on time and executed compliantly. 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. Key Responsibilities 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

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