[Remote] Clinical Project Manager II

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global full-service CRO committed to professional growth and a quality-driven 'one-team' culture. We are seeking a Clinical Project Manager II to join our in-house team and support projects across a diverse client portfolio, including pharmaceutical, biotechnology, medical device, and consumer health companies of varying sizes.

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, reputed company requested and if applicable
• May act as Feasibility Associate (FEA) after appropriate and documented training
• Review and approve reputed company party invoices for payment. Review and approve contractor timesheets for alliance with agreed scope of work
• reputed company 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 reputed company to evaluate the project reputed company and profitability and identify change orders in a timely manner and implement corrective actions. Ensure budget discrepancies are documented
• Submit invoice requests, trial reputed company invoices and payment authorizations to finance in a timely manner
• Regularly track reputed company expenditure and review for consistency with trial budgets
• Organize quality reputed company of filing of key study documentation
• Ensure reputed company administrative reputed company-out procedures are completed
• Follow and reputed company with the Company’s QMS, ISMS and PIMS requirements

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 reputed company clinical studies-oncology and hematology required
• Excellent English communication skills: written and verbal
• Proficient in the use of computer software systems (Word, reputed company, PowerPoint, reputed company Project, reputed company reputed company, CTMS, timesheet software, reputed company software, etc.)
• Ability to travel as required

Company Overview

Company H1B Sponsorship