Clinical Trial Manager

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

Clinical Trial Manager

W2 Contract-to-Hire

Base Pay

$70.00/hr - $80.00/hr

Salary Range

$145,600 - $166,400 per year

Location

Redwood City, CA - Hybrid Role

Job Summary

As a Clinical Trial Manager, you will be responsible for managing one or more Phase 1 studies or complex components of larger trials with cross‑functional oversight and vendor management.

Duties and Responsibilities

• Apply advanced expertise and exercise considerable latitude to determine objectives and to develop effective solutions to guide the successful completion of complex assignments under limited supervision.
• Participate in the Clinical Study Execution Team (CSET) discussion and may lead aspects of the meeting agenda as it pertains to vendors, study metrics, etc.
• Drive site activation and document readiness activities; analyze enrollment and operational metrics to support the study lead in decision‑making.
• Participate and sometimes lead meetings internally and externally with CROs, vendors, and multi‑functional teams with minimal supervision.
• Lead TMF reconciliation and inspection readiness activities.
• Support the review of study documents such as protocols, ICFs, CRFs, monitoring plans, etc.
• Lead department process improvement initiatives.
• Participate in CROs/vendor trainings as it relates to a limited aspect of study requirements.
• Manage the CRO and some ancillary vendors and ensure deliverables.
• May participate in the interview process for similar or junior roles within Clinical Operations.
• Mentor and support Clinical Trial Assistants (CTAs) and Clinical Trial Management Associates (CTMAs).
• Follow up and follow through on team action items and identification, escalation, and resolution of issues as needed.
• Review and identify trends when performing routine data surveillance of data listings, and support in the preparation of interim and final Clinical Study Reports and the resolution of data discrepancies.
• Support other Clinical Operations activities as appropriate.

Requirements and Qualifications

• BS, BA, or RN in a relevant scientific discipline.
• 1+ years of relevant experience in the pharmaceutical or biotech industry, preferably in Clinical Operations or Clinical Research-related experience.
• Advanced knowledge of FDA and EMA Regulations, ICH Guidelines, GCP, and familiarity with standard clinical operating procedures.
• Strong communication and coordination skills; global trial experience and strong operational judgement.
• Proactive contributor to trial execution and issue resolution, with strong ownership of responsibilities for complex studies with multiple sites.
• High sense of priority and commitment to excellence in the successful execution of deliverables.
• Ability to analyze operational data, perform with an emphasis on quality, timeliness, and multitasking, prioritize tasks, anticipate challenges, and execute on goals as a member of an interdisciplinary team.
• Travel may be required (~15%).

Preferred Qualifications

• Has familiarity working with vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS).
• Oncology experience, early and/or late stage, strongly preferred.

Desired Skills and Experience

Clinical Operations, Clinical Research, Oncology, Phase I studies, vendor management, cross‑functional oversight, FDA Regulations, EMA Regulations, ICH guidelines, GCP, SOPs, CSET, ICFs, CRFs, monitoring plans, Trial Master File, eTMF, EDC, IRT, CTMS, travel

Additional Information

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

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Seniority Level

Mid‑Senior level

Employment Type

Contract

Job Function

Research and Science