Clinical Project Manager II

This is a fully remote position, open to applicants in United States.

📋 Description

• Organizes and takes part in Investigator and Monitor Meetings.

• Conducts co-monitoring visits for assigned clinical projects as needed.

• After receiving appropriate and documented training or having relevant experience, undertakes site monitoring for assigned projects when required and applicable.

• May serve as a Feasibility Associate (FEA) following proper training.

• Reviews and approves third-party invoices for payment. Reviews and approves contractor timesheets to ensure alignment with the agreed scope of work.

• Develops and implements alternative strategies to address issues related to study timelines, resources, budgets, and more.

• Ensures that issues are recognized and communicated by the study team. Implements corrective action plans to prevent the recurrence of critical issues.

• Evaluates the scope of work and timelines against contractual agreements and proactively identifies change orders.

• Manages any deviations in resources and hours allocated to the project to assess progress and profitability, while identifying change orders promptly and implementing corrective actions. Ensures that budget discrepancies are properly documented.

• Submits invoice requests, trial-related invoices, and payment authorizations to finance promptly.

• Regularly monitors all expenses and ensures consistency with trial budgets.

• Organizes quality checks for the filing of essential study documentation.

• Ensures the completion of all administrative close-out procedures.

• Adheres to the Company’s QMS, ISMS, and PIMS requirements.

⛳️ Requirements

• University Degree in scientific, medical, or paramedical fields.

• A minimum of three (3) years of Project Management experience in the CRO/Pharmaceutical industry, or at least six (6) years of experience as a CM/CRA in a CRO/Pharmaceutical setting.

• Strong knowledge of clinical trial operations, GCP/ICH Guidelines, and other relevant regulatory requirements.

• Experience managing complex clinical studies, specifically in oncology and hematology, is required.

• Exceptional English communication skills, both written and verbal.

• Proficient in various computer software systems, including Word, Excel, PowerPoint, Microsoft Project, SharePoint, CTMS, timesheet software, and EDC software.

• Willingness to travel as necessary.

🏝️ Benefits

• Health insurance

• Paid time off

• Professional development opportunities