ClinChoice - Clinical Project Manager II
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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. • The Application Process • Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. • Who will you be working for? • ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare! • Our Company Ethos • Our Company Ethos • Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset, and they are the fulcrum around which all ClinChoice activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.
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.
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