Clinical Operations Leader / Clinical Trial Manager - FSP

Clinical Operations Leader

The Clinical Operations Leader is responsible for the execution of study-level activities including but not limited to creating and updating trial-specific documents, vendor oversight & delivery, compound training and country and regional oversight of CRO operational delivery. This includes alignment on the feasibility strategy, target setting, risk reviews, and country challenges that could impact overall study delivery.

Oversight of Project Cycle

• Manage integration of project team activities
• Manage strategic study operations including but not limited to study sites and tracking systems for regulatory submissions, drug supply and use, enrollment of subjects, regulatory document flow, study timelines, budget and financial information, performance metrics, and data flow
• Provide input on trial level operational strategies for clinical trials from protocol design to the final clinical study report for specific studies
• Provide input into global subject / patient recruitment plans
• Manage aspects of CRO / vendor identification and the day-to-day operational management activities of CROs and other vendors including set up, statement of work creation, and budget oversight
• Create and update critical trial-specific documents
• Support development of compound and protocol level training materials
• Review and provide input into budgets, timelines, and forecasts for assigned clinical studies
• Provide support for inspection readiness activities including risk identification and mitigation plans at the trial level
• Participate in process improvement activities at a trial and department level as needed

Collaborative Relationships

Compliance with Parexel Standards

Skills

Knowledge and Experience

Education

EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.