Clinical Trial Manager

Clinical Trial Manager

W2 Contract-to-Hire

Salary Range : $156,000 - $176,800 per year

Location : Redwood City, CA - Hybrid Role

Job Summary :

This is a unique opportunity for a Clinical Trial Manager. You will be responsible for independently managing one or more Phase 1-3 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, supporting 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 they relate 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 resolution of data discrepancies.
• Support other Clinical Operations activities as appropriate.

Requirements and Qualifications :

Preferred Qualifications :

Desired Skills and Experience

Clinical Trial Manager, Phase 1-3 studies, cross-functional oversight, vendor management, Clinical Study Execution Team (CSET), CRO management, site activation, document readiness, enrollment metrics, operational metrics, TMF reconciliation, inspection readiness, protocol review, ICF review, CRF review, monitoring plans, process improvement, Clinical Trial Assistant mentoring, Clinical Trial Management Associate mentoring, data surveillance, data listings, Clinical Study Reports, data discrepancies, FDA regulations, EMA regulations, ICH Guidelines, GCP, clinical operations, pharmaceutical industry, biotech industry, global trial experience, operational data analysis, eTMF, EDC, IRT, CTMS, oncology experience, early stage trials, late stage trials

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

Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s CCPA Privacy Policy at