Biibhr

Senior Clinical Monitoring Lead

Remote, USA · Senior

Sponsorship not specified$162k-$223kDetected 9 days ago

GCPPerformance ManagementClinical TrialsClinical ResearchFDA RegulatoryResearchLeadershipCommunicationProblem SolvingMentoring

About the role

You will oversee Site Managers and Clinical Trial Coordinators, 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.

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.

You are a dedicated professional with a strong background in clinical research and a passion for ensuring high-quality and compliant trial execution.

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.

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.

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 Biibhr's careers page and normalized into a canonical job model.