Clinical Project Manager II

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🏥 Clinical Operations

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ClinChoice

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1998

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

ClinChoice is a global full-service contract research organization (CRO) established in 1995, specializing in clinical development, post-marketing, and functional service support for the pharmaceutical, biotechnology, and medical devices industries. They provide comprehensive solutions from early clinical development to post-approval lifecycle management, with expertise in a variety of therapeutic areas such as autoimmune and inflammation, dermatology, endocrinology, infectious diseases, neuroscience, and oncology. ClinChoice aims to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. The company supports its clients with clinical, regulatory, and operational expertise across all phases of product development.

📋 Description

• 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.

🏖️ Benefits

• Professional growth • Quality-driven culture • Flexibility in work arrangements