Full-Time CSO Monitoring & Resourcing Manager

The CSO Monitoring & Resourcing Manager plays a pivotal role in ensuring Biogen’s clinical trial operations are efficiently resourced, monitored, and executed at the highest quality standards. This position leads regional Clinical Research Associate (CRA) resourcing and line management, supervises both in-house and outsourced CRAs, and drives operational excellence through resource planning, skill development, and quality oversight.

As a key contributor to the success of clinical trials, the CSO Monitoring & Resourcing Manager is responsible for mentoring the CRA team, addressing training needs, and supporting the implementation of innovative monitoring processes, tools, and risk-based monitoring strategies.

The role requires close collaboration with Functional Managers, FSP (Functional Service Provider) vendors, and internal stakeholders to ensure adequate CRA resourcing, adherence to regulatory and organizational standards, and alignment with study timelines and budgets.

Key Responsibilities:

1. CRA Resourcing and Line Management (as assigned): Lead regional CRA resourcing efforts, ensuring the appropriate allocation of in-house and outsourced CRAs to support clinical trial timelines. Supervise, mentor, and provide line management for the CRA team, addressing training needs and performance development. Collaborate with Functional Managers and FSP vendors to ensure seamless resource planning and operational alignment. Monitor CRA workload allocation to optimize resourcing efficiency and maintain a balanced distribution of responsibilities.
2. Training and Skill Development: Assist with CRA training and skill development to ensure team readiness for operational and regulatory challenges. Conduct accompanied visits to mentor CRAs, provide feedback, and address training gaps. Develop and implement tailored training programs and plans to enhance CRA competencies and career development. Support the development and ongoing review of monitoring SOPs.
3. Monitoring Processes and Strategies: Develop, implement, and continuously improve monitoring processes, tools, and risk-based monitoring strategies to enhance trial quality and efficiency. Ensure adherence to monitoring guidelines, SOPs, and regulatory requirements to maintain high standards of trial execution. Identify opportunities to streamline monitoring workflows and integrate best practices into day-to-day operations.
4. Quality Metrics and Operational Efficiency: Monitor quality metrics and key performance indicators (KPIs) to assess CRA performance and identify areas for improvement. Contribute to operational efficiency by analyzing performance data and providing actionable insights for process optimization. Ensure timely and accurate reporting of resourcing and monitoring metrics to leadership for strategic decision-making.
5. Resource Planning and Forecasting: Plan for adequate CRA resourcing based on study start-up, enrollment timelines, and regional requirements. Maintain accurate headcount tracking and forecasts for CRA resources, both in-house and outsourced, across clinical studies. Submit and track resource requests while ensuring alignment with study timelines and budget constraints. Coordinate onboarding and offboarding processes for CRA resources, ensuring smooth transitions and adherence to organizational policies.

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