Job Description

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:

• 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.
• 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 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.
• 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.
• 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.

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 7-10 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, risk-based monitoring strategies, and clinical trial quality metrics.
• Skills:
  • Exceptional leadership and line management skills, with the ability to mentor and develop high-performing 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 $131,000-175,000. 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 long-term 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 well-being; including, but not limited to:   

• Medical, Dental, Vision, & Life insurances  

• Fitness & Wellness programs including a fitness reimbursement    

• Short- and Long-Term Disability insurance   

• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 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 $10,000 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 mid-sized biotechnology company, we provide the stability and resources of a well-established 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 life-changing 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 E-Verify Employer in the United States.