Clinical Project Manager
- Expired: May 14, 2021. Applications are no longer accepted.
Job DescriptionNextCure is a start-up biopharmaceutical company located in Beltsville, MD, and focuses on the discovery and development of novel immunomedicines for the treatment of cancer and other diseases. We are seeking a highly motivated Clinical Project Manager to support NextCure Data Management for the successful delivery of our product pipeline. The candidate must thrive and adapt to a fast-paced, innovative and changing environment.Responsibilities Act as project manager on one or more projects Development and maintenance of the assigned project management plan and study manual(s) Plan, conduct, and manage research projects within the relevant regulations and policies Maintain assigned project regulatory documents as per NextCure guidelines and SOPs Align internal business needs and expectations with external CRO partners Facilitate communications with CROs and Vendors to ensure satisfaction Assist in preparation of project invoices Ensure site management...
follows the study plans Track all aspects of the research project and make regular progress reports Maintain regular communications with the study teams Identify issues and challenges and work with NextCure Director(s) to resolve any matters Participate in regular activities of Clinical Operations Team Plan and execute planning, procurement, assessments, and implementations Ensure regulations are being implemented according to ICH GCP, SOPs Manage projects process and procedures to meet set timelinesEducation and Experience: Master's in Science, Clinical Research Administration, or related field Minimum of 5 years prior relevant experience in the industry or relevant clinical research organization Prior project management/clinical operations experience Excellent working knowledge of FDA & ICH/GCP regulations and guidelines Experience building clinical operations groups and associated infrastructure Ability to travel 10% (after Covid)Qualifications: Good understanding of the drug development process Experience/understanding of the overall Clinical Trial process Good understanding of potential risks around clinical trial data collection Experience creating process flows, build process maps, conduct gap analysis, and outline process optimization Project management skills including expertise in metrics analysis and reporting methodologies Strong experience with MS Project, Excel (pivot tables, graphing) and PowerPoint Experience in handling multiple special projects along different touch points of the clinical lifecycleNextCure is an Equal Opportunity Employer and offers a competitive salary and benefits package in a scientifically engaged team work environment
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