Senior Clinical Monitoring Lead

Biogen

3d•$162,000 - $223,000•Hybrid

About The Position

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.

Requirements

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.

Nice To Haves

Advanced degree in life sciences or related field.
Experience with global clinical trial management.
Familiarity with advanced clinical monitoring tools and technologies.

Responsibilities

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.

Benefits

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