Biogen
Senior Clinical Monitoring Lead
Remote, USA · Senior
Sponsorship not specified$162k-$223kDetected 8 days ago
GCPPerformance ManagementClinical TrialsClinical ResearchFDA RegulatoryResearchLeadershipCommunicationProblem SolvingMentoring
About the role
- You will oversee Site Managers ensuring effective monitoring of clinical sites, adherence to ICH-GCP and SOPs, and timely resolution of study issues.
- By bringing your expertise and dedication, you will contribute significantly to the success of our clinical trials and the broader business objectives.
Responsibilities
- Lead and manage Site Managers in all aspects of site monitoring, including site selection, initiation, routine monitoring, and close-out.
- 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.
Requirements
- You are a dedicated professional with a strong background in clinical research and a passion for ensuring high-quality and compliant trial execution.
Nice to have
- Bachelor's degree in life sciences, nursing, pharmacy, or related field
- advanced degree preferred.
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).
- Advanced degree in life sciences or related field.
- Experience with global clinical trial management.
- Familiarity with advanced clinical monitoring tools and technologies.
Compensation
- Tuition reimbursement of up to $10,000 per calendar year
Benefits
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Paid Maternity and Parental Leave benefit
- 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)
- Employee stock purchase plan
- 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.
Company info
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 401(k) program participation with company matched contributions
- 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.
This listing is sourced directly from Biogen's careers page and normalized into a canonical job model.