Clinical Trial Lead - Cross-Functional Ops

Bayside Solutions; California (MO); On-site; USD 95,000 - 130,000; Full time

Job summary

Bayside Solutions, a biotechnology-focused firm, seeks an experienced Contract Clinical Trial Manager to lead trials from startup through closeout. You will coordinate with Regulatory Affairs, Clinical Pharmacology, QA, Legal, Data Management and Biostatistics to ensure study progression and compliance.

Responsibilities include vendor management (Central Lab, IRT, CRO), TMF oversight, protocol development support, and budget tracking.

Qualifications

• Bachelor's degree with 5-8 years, or master's degree with 5 years, of Clinical Operations experience in the pharmaceutical/biotechnology industry
• Thorough knowledge of ICH/GCP guidelines
• Experience in the Clinical Study Lead role from startup through closedown and cross-functional leadership
• Experience successfully managing vendors independently, including Central Lab, IRT, and CRO vendors"],
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Responsibilities

• Supporting the conduct, management, and completion of assigned clinical trials under the leadership and guidance of the Clinical Study Lead.
• Partnering with team members and other functional areas to perform study-related activities.
• Providing accurate and up-to-date information, including study status reports, to the study team members.
• Timely issue escalation to the Clinical Study Lead and assisting with the resolution of issues.
• Ensuring significant issues that affect the timeline, budget, or resourcing are escalated appropriately.
• Supporting development of key study documents (Protocol, ICFs, CSRs, etc.).
• Reviewing/approving study work orders, change orders, and invoices.
• Managing the study vendor selection process, including RFIs, budget negotiation, and change orders.
• Oversight of study systems (Central Lab, IRT) and TMF throughout the study.
• Maintaining contact with CRO and study vendors and QA audits.
• Preparing details for initial public trial registration and ensuring changes are reviewed, approved, and submitted.

Skills

Clinical Trial Management

Clinical Operations

Vendor Management

TMF oversight

ICH-GCP Compliance

Cross-Functional Leadership

Project Management

Risk Management

Study Start-Up and Closeout

CRO Oversight

Site Budget Negotiation

Contract and Invoice Review

Study Budgets

Regulatory Compliance

Inspection Readiness

Clinical Study Documentation

Patient Safety

IP Forecasting

Quality Assurance

Education

Bachelor's degree in a related field

Master's degree in a related field

Tools

Microsoft Word

Microsoft Project

PowerPoint

Excel

SharePoint

Job description

Bayside Solutions, a biotechnology-focused firm, seeks an experienced Contract Clinical Trial Manager to lead trials from startup through closeout. You will coordinate with Regulatory Affairs, Clinical Pharmacology, QA, Legal, Data Management and Biostatistics to ensure study progression and compliance.

Responsibilities include vendor management (Central Lab, IRT, CRO), TMF oversight, protocol development support, and budget tracking.