CSO Monitoring Resourcing Manager

The CSO Monitoring & Resourcing Manager plays a pivotal role in ensuring Biogens 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 inhouse 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 riskbased 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:

• CRA Resourcing and Line Management (as assigned):
  • Lead regional CRA resourcing efforts ensuring the appropriate allocation of inhouse 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.
• 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.
• Monitoring Processes and Strategies:
  • Develop implement and continuously improve monitoring processes tools and riskbased monitoring strategies to enhance trial quality and efficiency.
  • Ensure adherence to monitoring guidelines SOPs and regulatory requirements to maintain high standards of trial . Identify opportunities to streamline monitoring workflows and integrate best practices into daytoday operations.
• 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 decisionmaking.
• Resource Planning and Forecasting:
  • Plan for adequate CRA resourcing based on study startup enrollment timelines and regional requirements.
  • Maintain accurate headcount tracking and forecasts for CRA resources both inhouse 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.

Qualifications :

Required Qualifications:

• Education:
  • University degree or an equivalent combination of education and experience required.
  • Advanced or graduate degree preferred for some disciplines.
• Experience:
  • Typically requires 710 years of experience in clinical operations CRA line  and resourcing management and/or functional service provider (FSP) oversight within the pharmaceutical or biotechnology industry.
  • Proven track record of managing CRA resourcing training and performance in a regional or global capacity.
  • Strong understanding of monitoring processes riskbased monitoring strategies and clinical trial quality metrics.
• Skills:
  • Exceptional leadership and line management skills with the ability to mentor and develop highperforming teams.
  • Strong project management and organizational skills with the ability to manage competing priorities and deliverables.

Additional Information :

The base compensation range for this role is $. Base salary offered is determined though an analytical approach utilizing a combination of factors including but not limited to relevant skills & experience job location and internal equity.  Regular employees are eligible to receive both short term and longterm incentives including cash bonus and equity incentive opportunities designed to reward recent achievements and recognize your future potential based on individual business unit and company performance.    

In addition to compensation Biogen offers a full and highly competitive range of benefits designed to support our employees and their families physical financial emotional and social wellbeing; including but not limited to:   

• Medical Dental Vision & Life insurances  

• Fitness & Wellness programs including a fitness reimbursement    

• Short and LongTerm Disability insurance   

• A minimum of 15 days of paid vacation and an additional endofyear shutdown time off (Dec 26Dec 31  

• Up to 12 company paid holidays 3 days off for Personal Significance  

• 80 hours of sick time per calendar year 

• Paid Maternity and Parental Leave benefit  

• 401(k) program participation with company matched contributions  

• Employee stock purchase plan    

• Tuition reimbursement of up to $10000 per calendar year    

• Employee Resource Groups participation 

Why Biogen

We are a global team with a commitment to excellence and a pioneering spirit. As a midsized biotechnology company we provide the stability and resources of a wellestablished business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning growth and expanding their skills. Above all we work together to deliver lifechanging medicines with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds cultures and perspectives make us a stronger and more innovative company and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex gender identity or expression sexual orientation marital status race color national origin ancestry ethnicity religion age veteran status disability genetic information or any other basis protected by federal state or local law. Biogen is an EVerify Employer in the United States.