Bayside Solutions · 8 hours ago
Business Manager, Global Patient Safety Operations
Bayside Solutions is seeking a Business Manager for Global Patient Safety Operations to support the effective execution of priorities and deliverables. The role involves providing operational support to the leadership team, managing workflows, coordinating meetings, and overseeing budget administration and contract management.
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Responsibilities
Provide direct business and operational support to the Head of Global Patient Safety Operations, including coordination of leadership priorities, commitments, deliverables, and operational planning activities
Support the GPS Operations Leadership Team by organizing workflows, tracking action items, and ensuring follow-through on decisions, deliverables, and agreed-upon outcomes
Plan, schedule, and support GPS Operations leadership meetings, including preparation of agendas and materials, documentation of meeting minutes, and tracking of actions and next steps
Serve as a coordination point between GPS Operations leadership and cross-functional partners in Global Patient Safety, Clinical Development, Regulatory Affairs, Development, Finance, Legal, and Procurement to support alignment and execution of shared initiatives
Support contract administration activities for GPS Operations, including coordination of contract documentation, tracking contract status and key milestones, maintaining contract trackers, and supporting interactions with Procurement, Legal, and Finance
Provide project management and leadership with cross-functional and department initiatives as directed by the Head of Global Patient Safety
Assist with onboarding, amendments, renewals, and extensions of vendor and CRO contracts by coordinating required inputs, documentation, and approvals
Support budget administration for GPS Operations, including tracking budget allocations, monitoring spend against budget, supporting invoice review and reconciliation, and maintaining budget trackers in partnership with Finance
Assist GPS Operations leadership with forecasting, budget planning, and preparation of budget-related materials and summaries, as appropriate to experience
Support oversight of Pharmacovigilance vendors and CROs by coordinating document exchange, tracking deliverables, monitoring contractual obligations, and maintaining organized trackers and records
Maintain accurate and well-organized departmental files, trackers, distribution lists, and contact lists to support operational efficiency, financial visibility, contract governance, and inspection readiness
Contribute to continuous improvement initiatives within GPS Operations by identifying opportunities to strengthen organization, communication, execution, contract administration, and budget management as the function scales
Qualification
Required
Bachelor's degree in natural or health sciences, or a minimum of 1 year of relevant industry experience in lieu of
Knowledge of Good Clinical Practice (GCP) Guidelines
Experience in clinical trial conduct and safety reporting
Good understanding of Software: MS Office 365 (Outlook, Word, PowerPoint, Excel), Adobe Acrobat, eTMF software, quality management systems (i.e., Veeva Systems)
Preferred
Master of Business Administration (MBA) degree or similar advanced education
Experience working with CROs/vendors and management of external resources is preferred
Business degree or experience working with leadership teams
Experience with Smartsheet and other project management tools and practices
Project Management Professional certification and/or advanced education
Reliable, self-motivated, focused, positive attitude, proactive, and solution-oriented problem solver, able to adapt to changes in priorities and tasks
Attention to detail and excellent written and verbal communication skills
Demonstrate the ability to manage time, prioritize tasks, and organize information effectively to meet timelines
Excellent interpersonal skills include the ability to work in cross-functional team environments and with external vendors