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Clinical Project Manager

NextCure Inc Beltsville, MD

  • Posted: over a month ago
  • Full-Time
Job Description

Job Description

NextCure 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 timelines


Education 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 lifecycle


NextCure is an Equal Opportunity Employer and offers a competitive salary and benefits package in a scientifically engaged team work environment. 

NextCure Inc

Address

Beltsville, MD
20705 USA

Industry

Healthcare

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