EVMS

  • Clinical Trial Project Manager

    Position Number
    2881406
    Department
    OB/GYN - CONRAD
    Category
    Management
    Compensation Max
    USD $126,587.00/Yr.
    Compensation Min
    USD $99,284.00/Yr.
    Location : Location
    US-VA-Arlington
  • Overview

    The Clinical Project Manager (CPM) is responsible for the planning and execution of assigned clinical trials from protocol design to the final study report, while adhering to budget, scope, and timelines.  The CPM is responsible for managing all aspects of a clinical trial or multiple clinical trials including vendor selection and oversight to ensure adherence to trial participant safety, protocol, contract, and data integrity.  The CPM will lead the planning and communication with cross-functional study teams to ensure the proper execution and conduct of the trial. The position is responsible for coordinating all efforts of clinical trial implementation both within CONRAD and through a wide variety of collaborators and vendors. The CPM serves as a primary resource for vendors and the Clinical Research Associates (CRAs).  Additional responsibilities include preparation, oversight, and review of all study related documents, including, but not limited to, contracts, protocols, informed consent forms, vendor and site budgets, annual reports, etc.  The CPM will organize and lead study team meetings as necessary.

      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 writing of protocols
    • Estimates project budgets, develops enrollment projections, and provides drug supply needs
    • Responsible for creating and maintaining timelines for each project, and uses timelines to track and manage a project’s progress
    • Supports selection and provides oversight and management of external vendors and consultants
    • Negotiates budgets and contracts with clinical sites, central laboratories, and external parties as necessary
    • Directs development of model informed consent forms
    • Directs development of CRF forms
    • Develops and reviews study-related support material and documents (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, database lock, and statistical report, results of laboratory analyses). Informs tcollaborators 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
    • Performs other duties as assigned

    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

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed