Global Study Manager
ICON Strategic Solutions
Global Study Manager - Oncology and/or Multi TA Global Study Managers provide operational leadership across the full clinical study lifecycle, ensuring timely delivery of high‑quality data and managing all study activities from sourcing strategy and RFP development through study start‑up, execution, database release, and inspection readiness. Key Responsibilities Lead and coordinate the operational sub team, identifying and requesting resources as needed. Develop realistic, detailed study start‑up and monitoring plans, including sourcing strategy, RFP input, vendor selection, and risk planning. Ensure country‑level feasibility is completed in collaboration with cross‑functional teams and approve site activation plans. Oversee PTMF setup for study management and country/site level documentation. Coordinate study/protocol training and global investigator meetings, including local investigator meeting support. Provide key inputs to the clinical trial budget, monitor cost variance, and review vendor invoices, contracts, and purchase orders. Monitor vendor performance and manage contracts for central labs, ePRO, radiology, pCRO, and other service providers. Lead inspection readiness activities related to study management and site readiness. Support development and delivery of decentralized capabilities at investigator sites. Manage study closure activities post‑database lock, including release of resources. Develop, review, or approve study start‑up, monitoring, and protocol recruitment plans, as well as related documents such as CRF Guidelines and training plans. Approve and oversee drug supply management, including supply flow and interactive randomization systems. Escalate vendor issues and coordinate with cross‑functional teams to resolve operational challenges. Review feasibility and pre‑trial assessment reports in partnership with functional colleagues. Support study‑level submission readiness and vendor UAT/system set‑up reviews when required. Lead and oversee all elements of study start‑up and monitoring functions, ensuring compliance with SOPs and quality standards. Align data flow with data management functions and provide regular risk reviews of data reports and dashboards. Provide operational input into protocol design and lead protocol deviation trend reviews. Manage vendor calls and serve as a technical expert for study management systems and processes. Champion harmonized, consistent processes and continuous improvement across the operational sub team. Qualifications Working knowledge of Good Clinical Practices, monitoring, and clinical and regulatory operations. Scientific or technical degree preferred with extensive knowledge of clinical trial methodology. BA/BS with 7+ years of relevant experience, or MBA/MS with 6+ years of relevant experience. Demonstrated clinical research and/or study management experience. Proven study management/leadership experience, including oversight of CROs/vendors. Experience managing per‑subject costs, vendor and ancillary spend projections, and budgets. Strong analytical and negotiation skills, with a track record of delivering cost‑effective, timely, and high‑quality data. Ability to work independently and mentor team members, driving continuous improvement. Benefits Competitive base salary and performance‑related incentives. Health and wellbeing programmes, including medical, dental, and vision coverage (where applicable). Retirement and pension plans. Life assurance and disability coverage. Employee assistance programmes and wellbeing resources. Learning and development opportunities through structured training and career pathways. Equal Opportunity Employer Employment with ICON is contingent upon having the legal right to work in the country where the role is based. ICON is an equal opportunity employer committed to building an inclusive and accessible workplace where everyone feels valued and supported. If you require reasonable accommodations during the recruitment process, please let us know or submit a request. #J-18808-Ljbffr ICON Strategic Solutions
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