Clinical Operations

• Financial Operations Advisor that leads and advises the full lifecycle of pre- and post-award fixed-price grants and contracts for the College of Medicine.
• Provides expert-level guidance with minimal supervision.
• Serves as key strategic resource for investigators, research staff and CCRM staff.
• Collaborates with funding agencies to develop, negotiate, and administer complex research budgets.
• Directs post-award financial management activities, including budget implementation, expenditure review and approval, and financial reporting.
• Proactively identifies and resolves budget variances, funding overruns, and compliance issues while ensuring adherence to sponsor guidelines.
• Oversees project closeout processes, including financial reconciliation and transfer of residual/overrun balances to investigator departments.

Research Financial Operations Advisor – Center for Clinical Research Management

• manage the implementation and installation of diagnostic instrumentation portfolio
• coordinate with laboratory customers, hospital facilities teams, IT stakeholders
• provide quality implementations with updates to Project Teams and Stakeholders
• act as the single point of contact between the customer and BCI
• maintain all project related documentation

Project Manager, Clinical Lab Equipment Installation

• Lead and manage global Phase I virology clinical trials from study start-up through closeout with minimal supervision
• Drive overall study execution, timelines, deliverables, risks, budgets, and operational performance
• Provide oversight and accountability for CROs, vendors, and cross-functional partners to ensure high-quality study execution
• Build strong collaborative relationships with Clinical Operations, Data Management, Regulatory, Medical, Clinical Supply, Biometrics, and other stakeholders
• Lead study team meetings by establishing clear agendas, facilitating productive discussions, documenting key decisions, and ensuring timely completion of action items
• Proactively identify operational risks, develop mitigation strategies, and drive issue resolution before timelines or quality are impacted
• Guide study teams through key transitions across the clinical trial lifecycle while ensuring seamless operational execution
• Maintain oversight of study documentation, trial metrics, operational deliverables, and inspection readiness activities
• Ensure compliance with GCP, SOPs, regulatory requirements, and sponsor expectations
• Foster accountability across study teams while creating an environment of collaboration, transparency, and shared ownership
• Contribute to process improvements and operational best practices that enhance study execution and team performance

Clinical Project Manager II – Virology, Phase I

• Line management of Clinical Operations staff, responsibilities including interviewing and selection, termination, professional development, performance appraisals, and employee counselling
• Participate in managing the resource availability for the assigned staff, providing support that projects are suitably resourced
• Provide expert operational oversight and guidance to support prioritization of activities
• Assist in recruiting new staff, including participation in interview process and new hire on boarding
• Ensure quality and adherence to Standard Operating Procedures/Work Instructions (SOP/WIs) and compliance with federal and local guidelines and ICH GCP
• Work closely within appropriate business unit/region to ensure staff performance on studies
• Organize and chair clinical staff meetings at regular intervals
• Facilitate and support project and team/country reviews with Clinical Operations staff

Manager, Clinical Operations – CRA Line Management, CRA Monitoring Experience Required

• Lead the strategic direction, selection, and performance management of clinical and pharmacy vendors
• Provide executive-level consultation on vendor strategy
• Drive vendor selection, contract negotiation, performance oversight, and risk management
• Serve as the primary interface between clinical program/strategy and other internal/external stakeholders
• Shape the enterprise's preferred partnership strategy roadmap
• Direct leadership in deciding whether to add, replace, or terminate a service line
• Develop and maintain a comprehensive multi-year roadmap
• Lead contract negotiations by establishing service level agreements (SLAs) and performance guarantees (PGs)
• Develop revenue model in conjunction with Finance
• Create and finalize all Program Descriptions and Order Forms for market launch
• Develop and implement key performance indicators (KPIs) and benchmarks
• Monitor contract terms and conduct proper oversight
• Identify and implement opportunities to enhance vendor management processes
• Draft the development of technical business requirements for project success
• Maintain regular communication with clinical vendors
• Partner with sales, technical, legal, procurement, and finance teams
• Present data and information to internal and external stakeholders
• Report to legal and risk any potential compliance or regulatory issues.

Clinical Vendor Program Manager

• Lead Biomarker Study Operations
• Oversee biomarker and bioanalytical activities across Sponsor and Collaborative programs
• Serve as the operational point of contact for all biomarker-related processes
• Work closely with clinical study teams (Phases 1–4) to integrate biomarker strategies into broader clinical development plans
• Plan and manage the collection, tracking, and analysis of biological specimens
• Advise study teams on best practices for sample management and logistics
• Lead cross-functional teams through the full clinical trial lifecycle, from start-up to closeout
• Ensure studies stay on track with respect to timelines, budget, scope, and quality
• Act as the main liaison between the sponsor and study partners
• Monitor and manage project financials, ensuring fiscal responsibility
• Proactively identify and resolve operational issues and risks
• Maintain high-quality documentation, including Trial Master File (TMF) accuracy and completeness
• Keep study systems and databases current and audit-ready
• Prepare project reports and updates for sponsors and internal stakeholders
• Plan and facilitate internal and external meetings
• Support inspection readiness and regulatory compliance throughout the project

Clinical Project Manager II – Biomarker Study Management

• Support the Study Lead and cross-functional study team in day-to-day clinical trial operations
• Support activities such as: Clinical Trial Team (CTT) meeting coordination and minutes, Clinical supplies planning and tracking, Lab specimen tracking and reconciliation, Imaging data reconciliation, Study status reporting and updates, Study closeout activities
• Contribute to single or multiple studies, depending on scope and complexity
• Lead smaller or limited-scope studies, as appropriate (e.g., survival follow-up studies)
• Track and manage study timelines using project management tools
• Collaborate with internal stakeholders and external partners, including investigative sites, vendors, and committees
• Support achievement of study milestones and clinical objectives

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