Clinical Project Manager II

Main Job Tasks and Responsibilities

• Organizes and participates in Monitor’s and Investigator’s Meetings.
• Performs, if necessary, co-monitoring visits for the assigned clinical projects.
• Carry out, after appropriate and documented training/past experiences, the monitoring of the sites for the assigned projects, when requested and if applicable.
• May act as Feasibility Associate (FEA) after appropriate and documented training.
• Review and approve third party invoices for payment. Review and approve contractor timesheets for alliance with agreed scope of work.
• Develop and implement alternative solutions to problems with study timelines, resources, budgets, etc.
• Ensure issues are identified and communicated by the study team. Implement corrective action plan to prevent repetition of critical issues.
• Assess scope of work and timelines against contractual agreements and identify change orders pro-actively.
• Manage any deviations on resources and hours spent on the project to be able to evaluate the project progress and profitability and identify change orders in a timely manner and implement corrective actions. Ensure budget discrepancies are documented.
• Submit invoice requests, trial related invoices and payment authorizations to finance in a timely manner.
• Regularly track all expenditure and review for consistency with trial budgets.
• Organize quality check of filing of key study documentation.
• Ensure all administrative close-out procedures are completed.
• Follow and comply with the Company’s QMS, ISMS and PIMS requirements.

Education, Experience and Skills

• University Degree in scientific, medical or paramedical disciplines.
• Three (3) years (at least) of Project Management experience in the CRO/Pharmaceutical industry or six (6) years (at least) of experience as CM/CRA in a CRO/Pharmaceutical industry.
• Excellent knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements.
• Experience managing complex clinical studies-oncology and hematology required.
• Excellent English communication skills:written and verbal.
• Proficient in the use of computer software systems (Word, Excel, PowerPoint, Microsoft Project, Share Point, CTMS, timesheet software, EDC software, etc.).
• Ability to travel as required.