About This Role:As a Senior Clinical Monitoring Lead, you will play a pivotal role in leading the clinical monitoring function within assigned studies to ensure high-quality trial execution and regulatory compliance. You will oversee Site Managers ensuring effective monitoring of clinical sites, adherence to ICH-GCP and SOPs, and timely resolution of study issues. The Sr. Clinical Monitoring Lead might have operational leadership over Clinical Monitoring Leads in larger / complex clinical trials. Your leadership will support operational readiness for inspections, data integrity, and consistency across all monitoring activities. In larger or complex clinical trials, you may provide operational leadership over Clinical Monitoring Leads, ensuring that all clinical monitoring functions align with the overall project goals. By bringing your expertise and dedication, you will contribute significantly to the success of our clinical trials and the broader business objectives.
What You'll Do:- Lead and manage Site Managers in all aspects of site monitoring, including site selection, initiation, routine monitoring, and close-out.
- Review monitoring visit reports and follow-up letters for accuracy, completeness, and compliance with protocol, SOPs, and regulatory requirements.
- Ensure consistent application of risk-based and centralized monitoring strategies across studies.
- Track and report on site performance, enrollment, data quality, and issue resolution.
- Ensure timely and accurate documentation in the Trial Master File (TMF) and support audit and inspection readiness.
- Partner with Quality Assurance to conduct root cause analyses and implement corrective and preventive actions (CAPAs).
- Supervise, coach, and mentor Site Managers, conduct performance reviews, and support professional development.
- Deliver training to Site Managers on protocol requirements, therapeutic area knowledge, and monitoring best practices.
- Collaborate with CTDU, CTAU, and other stakeholders to align on trial execution operational strategies.
- Act as a subject matter expert on monitoring execution for internal and external partners.
- Manage all aspects of monitoring operations and quality for allocated studies, ensuring compliance with ICH GCP and applicable local regulations.
- Contribute to the development of clinical tools and documents.
Who You Are: You are a dedicated professional with a strong background in clinical research and a passion for ensuring high-quality and compliant trial execution. Your leadership skills enable you to mentor and guide your team effectively, fostering professional growth and operational excellence. You possess a keen eye for detail and thrive in a dynamic environment where you can apply your problem-solving abilities to drive performance and resolve study issues efficiently. Your ability to build relationships across the organization and operate effectively in a hybrid or remote setup makes you an invaluable asset to the team.
Required Skills:- Bachelor's degree in life sciences, nursing, pharmacy, or related field; advanced degree preferred.
- Minimum of 10 years of clinical research experience, including at least 3 years as a CRA.
- Minimum of 5 years in CRA management, mentoring, or monitoring oversight.
- Strong understanding of ICH-GCP, FDA/EMA regulations, and global clinical trial guidelines.
- Demonstrated experience in CRA performance management and inspection readiness.
- Excellent organizational, leadership, and problem-solving skills.
- Strong communication skills, both written and verbal.
- Willingness to travel (20-30%, as required).
- Ability to build relationships across the organization and operate effectively in a hybrid or remote environment.
- Proven ability to manage multiple tasks of varying complexity within tight timelines and shifting priorities.
- Strong leadership skills with the ability to influence and drive performance across clinical trial teams.
Preferred Skills:- Advanced degree in life sciences or related field.
- Experience with global clinical trial management.
- Familiarity with advanced clinical monitoring tools and technologies.
Job Level: Management
Additional InformationThe base compensation range for this role is: $162,000.00-$223,000.00
Base salary offered is determined through 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 paid 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
Job Level: Management
Additional InformationThe base compensation range for this role is: $162,000.00-$223,000.00
Base salary offered is determined through 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 paid 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
Job Level: Management
Additional InformationThe base compensation range for this role is: $162,000.00-$223,000.00
Base salary offered is determined through 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 paid 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
