Senior Global Clinical Trial Manager

Lakefront Biotherapeutics, Inc.; San Francisco (CA); On-site; USD 150,000 - 165,000; Full time

Job summary

Lakefront Biotherapeutics is seeking a Clinical Trial Manager to oversee operational aspects of selected clinical studies from start-up through final reporting. You will manage timelines, budgets, vendor selection, site management, and input into study processes to ensure quality and regulatory compliance.

You will lead cross‑functional teams, coordinate CROs and vendors, and drive data quality, documentation, and continuous improvement. Prior experience in autoimmune/rare diseases is a plus.

Qualifications

• BS/BA in life sciences or related field.
• 5–7 years in clinical operations in biotech/pharma; autoimmune/rare disease desirable.
• Direct global study management experience preferred.
• Proficiency in Excel; ability to create metrics and dashboards.
• Experience with clinical systems (EDC, IRT, TMF, CTMS).

Responsibilities

• Oversee clinical study execution and all operational aspects.
• Organize regular study team meetings and escalate issues.
• Select and manage CROs/third-party vendors.
• Oversee vendor performance and study documentation.
• Ensure regulatory and procedural compliance (ICH/GCP).
• Collaborate with Data Management on data quality and cleaning.
• Manage study budgets and vendor invoices.
• Provide guidance to internal and external partners.

Skills

Excel proficiency

Cross-functional collaboration

Clinical operations

Global trial management

Regulatory knowledge

Education

BS/BA in life sciences or related field

Tools

EDC

IRT

TMF

CTMS

Job description

Lakefront Biotherapeutics is seeking a Clinical Trial Manager to oversee operational aspects of selected clinical studies from start-up through final reporting. You will manage timelines, budgets, vendor selection, site management, and input into study processes to ensure quality and regulatory compliance.

You will lead cross‑functional teams, coordinate CROs and vendors, and drive data quality, documentation, and continuous improvement. Prior experience in autoimmune/rare diseases is a plus.