Clinical Project Manager II

ClinChoice is a global full-service CRO committed to professional growth and a quality-driven culture. They are seeking a Clinical Project Manager II to oversee and deliver clinical studies, manage vendor and site activities, and ensure compliance with regulatory requirements.

Responsibilities:

• Organizes and participates in Monitor’s and Investigator’s Meetings
• Performs, if necessary, co-monitoring visits for the assigned clinical projects
• Carries 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

Requirements:

• 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