The Business Manager, Clinical Site Operations serves as a strategic partner to the Director of Clinical Site Operations through collaboration with Site Operations, Study Management, Clinical Data Systems, Clinical Planning & Performance, and GCO leadership. Key responsibilities include activation readiness governance, portfolio site activation forecasting, startup risk identification and mitigation, executive reporting, operational analytics, and strategic initiatives.
This role serves as a force multiplier for Clinical Site Operations leadership by expanding organizational capacity for portfolio intelligence, proactive risk management, forecasting, and operational planning. The individual will facilitate readiness reviews, coordinate mitigation planning and follow-up, support reporting automation initiatives, and translate complex operational data into actionable business insights. This enables leadership to focus on execution, decision-making, and stakeholder engagement rather than manual data gathering and report preparation.
The role will also support the development of a future-state Site Intelligence capability and help establish a scalable source of truth for startup, activation, and portfolio readiness metrics
Essential Functions:
- Facilitate Activation Readiness Reviews and associated portfolio governance meetings.
- Monitor startup milestones, activation forecasts, readiness indicators, and study level risks in partnership with Site Operations and Study Management leadership.
- Lead proactive identification, assessment, escalation, and tracking of startup and activation risks across the portfolio, driving alignment and accountability for mitigation actions.
- Support quarterly forecasting, resource planning, and portfolio readiness assessments.
- Develop and maintain executive dashboards, portfolio scorecards, and activation readiness reporting.
- Provide rapid responses to leadership requests regarding startup performance, activation readiness, site intelligence, enrollment readiness, portfolio risks, forecasting assumptions, and key milestones.
- Identify portfolio trends, risks, opportunities, and operational bottlenecks and provide actionable recommendations to leadership.
- Translate complex operational metrics into executive-ready insights and recommendations, creating clear narratives around study startup performance, activation readiness, portfolio health, and emerging risks.
- Tailor communications and reporting to the needs of GCO leadership and executive stakeholders.
- Partner with Clinical Data Systems, Study Management, and Site Operations to define and implement a scalable source of truth for startup, activation, and site intelligence metrics.
- Support reporting automation initiatives and drive reduction of manual reporting burden through process standardization and technology-enabled solutions.
- Lead and support strategic initiatives focused on operational excellence, startup process optimization, reporting modernization, site intelligence capabilities, and future-state portfolio management solutions.
Other Duties:
- 1. Has strong knowledge of current clinical regulations and common industry practices. Engages in relevant professional associations or societies and seeks continuing education about devices and therapies.
- 2. May support ad-hoc projects and process improvement efforts that are critical to help support departmental goals and objectives.
- 3. May participate in Core Team activities and make additional contributions as assigned.
- 4. This position might require up to 20% travel.
Qualifications:
Required:
- Bachelor's degree required.
- 5+ years of experience in Clinical Operations, Clinical Site Operations, Study Management, Clinical Project Management, Portfolio Operations, Program Management, Business Operations, Strategy, Analytics, or related functions.
- Experience supporting clinical study startup, activation, site operations, and/or clinical portfolio management.
- Experience facilitating cross-functional meetings, operational reviews, and leadership discussions.
- Experience developing dashboards, reporting tools, business intelligence solutions, and executive presentations.
- Strong analytical, communication, stakeholder management, facilitation, and problem-solving skills.
- Strong written and verbal communication skills with the ability to communicate effectively across all organizational levels through executive leadership.
- Strong project/program management skills with demonstrated ability to manage multiple priorities in a fast-paced environment.
Preferred:
- Medical device clinical research experience.
- Clinical Site Operations experience.
- Clinical trial startup and activation experience.
- Portfolio forecasting and operational planning experience.
- Experience partnering with Clinical Data Systems, reporting teams, and technology organizations.
- Experience with Power BI, Tableau, Smartsheet, SQL, or similar analytics platforms.
Core Competencies:
- Data Analytics & Business Intelligence
- Stakeholder & Cross-Functional Management
- Strategic Thinking & Navigating Ambiguity