Phase I Clinical Trial Manager - Hybrid Role

Bayside Solutions; Santa Clara (CA); Hybrid; USD 145,600 - 166,400; Full time

Job summary

A leading biotech firm in California is seeking a Clinical Trial Manager to oversee Phase 1 studies with vendor management. Responsibilities include driving site activation, managing cross-functional teams, and ensuring compliance with FDA and EMA regulations. Candidates should have a BS, BA, or RN in a scientific discipline and at least 1 year of industry experience. The position is hybrid and offers a contract-to-hire opportunity with a competitive pay rate.

Qualifications

• 1+ years of relevant experience in the pharmaceutical or biotech industry.
• Advanced knowledge of FDA and EMA Regulations, ICH Guidelines, GCP.
• Strong communication and coordination skills.

Responsibilities

• Manage one or more Phase 1 studies or complex components of larger trials.
• Drive site activation and document readiness activities.
• Mentor and support Clinical Trial Assistants (CTAs).

Skills

Clinical Operations

Clinical Research

Oncology

Vendor management

FDA Regulations

EMA Regulations

ICH guidelines

GCP

Education

BS, BA, or RN in a relevant scientific discipline

Tools

eTMF

EDC

IRT

CTMS

Job description

A leading biotech firm in California is seeking a Clinical Trial Manager to oversee Phase 1 studies with vendor management. Responsibilities include driving site activation, managing cross-functional teams, and ensuring compliance with FDA and EMA regulations. Candidates should have a BS, BA, or RN in a scientific discipline and at least 1 year of industry experience. The position is hybrid and offers a contract-to-hire opportunity with a competitive pay rate.