EVMS

Clinical Trial Project Manager

Position Number
2881406
Department
OB/GYN - CONRAD
Category
Management
Compensation Max
USD $124,104.00/Yr.
Compensation Min
USD $97,337.00/Yr.
US-VA-Arlington

Overview

The Clinical Project Manager is responsible for the execution of assigned clinical trials from protocol design to the final study report.  The position is responsible for coordinating all efforts of trial implementation both within CONRAD and through a wide variety of collaborators and vendors.  This position is located in Northern Virginia in our Arlington, VA office.

Responsibilities

  • Manages project teams to deliver high quality clinical trial(s)
  • Drives all aspects of the project management process from planning, execution, control and closure.  Manages all aspects proactively.
  • Works with functional areas on planning, initiating, executing, closing and resourcing for clinical trials (e.g., product development, data management and stats, regulatory)
  • Assists in preparation of study design and responsible for writing of protocols
  • Estimates project budgets, develops enrollment  projections, and drug supply needs
  • Responsible for creating and maintaining timelines for each project, and uses timelines to track and manage a project’s progress
  • Negotiates budgets and contracts with clinical sites and central laboratories
  • Directs development of model informed consent forms
  • Directs development of CRF forms
  • Reviews study-related support materials (e.g., study manual, monitoring plan, and edit checks)
  • Reviews trial conduct and quality at all levels (e.g., monitoring, data management)
  • Responsible for periodic study team meetings
  • Responsible for overseeing monitoring and evaluation of project milestones
  • Reviews study metrics for performance and quality with the team and management
  • Ensures review of Clinical Trial Master File for completeness
  • Oversees preparation of clinical study reports and manuscript(s)
  • Ensures collaborators provide deliverables (e.g., query generation resolution, data base lock, and statistical report, results of laboratory analyses).  Informs these groups of timelines.
  • Has overall responsibility for ensuring study conduct is completed in a timely manner and in compliance with all regulations and SOPs
  • Serves as primary contact and resource for CRAs and when applicable, vendor personnel.
  • Performs monitoring or co-monitoring activities as needed

Qualifications

Bachelor's degree in related field and five years relevant experience is required.  Master's degree (MPH, MSN) is preferred.

 

TECHNICAL SKILLS:  The candidate must have a strong understanding of clinical trials including knowledge of the Code of Federal Regulations, ICH-GCP guidelines, and other applicable regulatory requirements.  European Clinical Trial Directive knowledge is also preferred.  The candidate should possess the ability to negotiate and manage competing priorities across multiple areas. The ideal candidate will display flexibility, integrity and must possess highly effective interpersonal skills to lead a team through negotiation and mentoring.   The candidate should also be well-organized and detail-oriented to manage multiple projects simultaneously and have problem-solving skills to work independently and effectively with a wide variety of medical, research and administrative personnel.

Proficient in MS Word/Excel/Project/PowerPoint.  Experience working with providers of clinical and regulatory information management systems a plus.

 

Location : Location

US-VA-Arlington

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