Senior Clinical Trial Operations Lead (Hybrid/Remote)

Protego Bio; San Diego (CA); Hybrid; USD 160,000 - 190,000; Full time

Benefits offered by this job

Stock options

401k plan with employer contribution

Dental and vision insurance

HSA, FSA, and supplemental insurance

Job summary

Protego Bio, a San Diego-based clinical-stage biotechnology company, seeks a Senior Clinical Trial Manager to lead day-to-day trial operations across phases, coordinating sponsor-CRO interactions and ensuring on-time, budget-conscious delivery.

The role requires 7–10 years in clinical operations with strong vendor management, data review, and regulatory knowledge, in a hybrid US setting.

Qualifications

• Bachelor's Degree in a related scientific field required; advanced degree a plus.
• Minimum 7-10 years of experience in clinical research/clinical operations, including direct CRO management.
• Experience managing early-stage Phase 1 studies is a plus.
• Knowledge of Mandarin is a plus.

Responsibilities

• Independently manage day-to-day operations of assigned clinical trial activities to meet milestones, budget and quality.
• Lead cross-functional study teams and identify operational risks with mitigation plans.
• Act as primary operational contact for sponsor and CRO/vendor teams.
• Manage CROs/work orders, change orders, and study invoices; monitor budget.
• Provide guidance to CRO monitors and review monitoring reports.

Skills

Clinical trial management

CRO management

ICH GCP knowledge

Regulatory compliance

CTMS/EDC proficiency

Vendor management

Cross-functional leadership

Data review & reconciliation

Education

Bachelor's degree in a related scientific field

Advanced degree a plus

Tools

CTMS

eTMF

EDC

MS Office

Job description

Protego Bio, a San Diego-based clinical-stage biotechnology company, seeks a Senior Clinical Trial Manager to lead day-to-day trial operations across phases, coordinating sponsor-CRO interactions and ensuring on-time, budget-conscious delivery.

The role requires 7–10 years in clinical operations with strong vendor management, data review, and regulatory knowledge, in a hybrid US setting.