Note: The job is a remote job and is open to candidates in USA. ClinChoice 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, 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
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
Company Overview
Company H1B Sponsorship