Clinical Trial Manager, Clinical Operations

Jobtailor; Deutschland; Vor Ort; EUR 90.000 - 130.000; Vollzeit

Zusammenfassung

RayzeBio is seeking an experienced Senior Clinical Operations professional to lead trials from planning through closeout across Phases I–III. You will oversee CROs and vendors, ensuring timeliness, budget adherence, and compliance with FDA, ICH/GCP, and RayzeBio SOPs.

You will coordinate cross-functional study teams, manage timelines and risks, and contribute to start-up activities, feasibility, and monitoring of site performance to optimize study execution.

Qualifikationen

• 5-7 years clinical operations experience in biotech, pharma or CRO.
• BA/BS in scientific or healthcare discipline preferred.
• Independent professional who proactively communicates frequently.
• Detail and action-oriented, organized and committed to quality and consistency.
• Ability to work successfully in cross-functional teams.
• Applies AI to improve team execution and decision-making.

Aufgaben

• Lead planning, execution, and closeout of clinical trials from Phase I–III.
• Oversee CROs and vendors to ensure studies are on time, within budget, and compliant with SOPs, FDA regulations and ICH/GCP.
• Lead cross-functional study execution team to achieve goals and deliverables.
• Plan and execute study timelines.
• Monitor progress, enrollment, site performance, data quality and risks; escalate as needed.
• Identify, assess, and mitigate operational risks; escalate issues as needed.
• Manage CRO/vendor budgets and invoicing per study contract.
• Lead feasibility, country/site activation strategies.
• Participate in CRO/vendor meetings and provide input on ops strategy.
• Summarize CRO/vendor/site performance data and escalate risks to leadership.
• Perform other related duties as assigned

Kenntnisse

Clinical operations

Project management

Cross-functional teamwork

Vendor management

Risk management

Communication

AI in operations

Ausbildung

BA/BS in science or healthcare

Tools

Microsoft Project

Smartsheets

Jobbeschreibung

Responsibilities

• Lead the planning, execution, and closeout of clinical trials from Phase I–III
• Oversee and manage CROs and vendors to ensure that the study(ies) are completed on time, within budget, and in compliance with RayzeBio SOPs, FDA regulations and ICH/GCP guidelines
• Lead the cross-functional study execution team in achieving the study goals and deliverables
• Plan and execute study timelines
• Monitor study progress, including enrollment, site performance, data quality, and key risk indicators and proactively escalates issues to key internal stakeholders to ensure timely resolution of issues
• Identify, assess, and mitigate operational risks; escalates issues as needed
• Manage study CRO and vendor budgets and invoicing procedures according to study contract
• Lead/support country and site feasibility, selection, and activation strategies
• Active participant in CRO and vendor meetings, responsible to review key CRO and vendor study operational plans and provides input to operational strategy, including country and site feasibility and start-up
• Summarize CRO, vendor and site performance data and escalates study risks to the Clinical Operations Program Lead / Head of Clinical Operations
• Perform other related duties as assigned

Requirements

• Minimum 5-7 years clinical operations experience within biotech, pharma or CRO industry
• BA/BS degree, scientific or healthcare discipline preferred
• Independent professional who proactively communicates frequently and effectively.
• Detail and action-oriented, organized and committed to quality and consistency.
• Ability to work successfully in cross‑functional teams.
• Ability to work in a dynamic environment with a high degree of flexibility.
• Expertise in Microsoft Project and Smartsheets desired.
• Applies AI to improve team execution and decision‑making.