ERT

  • Consulting Project Manager (Cardiac Safety Clinical Trials)

    Job Location US-PA-Philadelphia
    Shift
    Fulltime/Regular
    Type
    Regular Full-Time
  • Overview

    Looking for a career when your work makes a difference? Join us as a Project Manager, Consulting Services and take responsibility for directing and managing services for client (cardiac safety clinical trial) projects and motivating team members to assure high quality, on-time, on-budget services while promoting excellent customer service.

     

    The Consulting Project Manager will work in conjunction with the broader study team, including the Chief Medical Officer (CMO), Chief Scientific Officer (CSO), Cardiac Safety Statistical Operations and Vendors, Business Development, Project Management, and the overall Project Assurance team to maximize the ability to provide superior service in the delivery of ERT consulting services. 

     

    ERT is a global data and technology company that minimizes uncertainty and risk in clinical trials so that customers can move ahead with confidence. With nearly 50 years of clinical and therapeutic experience, ERT balances knowledge of what works with a vision for what’s next, so we can adapt without compromising standards.


    Powered by the company’s EXPERT® technology platform, ERT’s solutions enhance trial oversight, enable site optimization, increase patient engagement and measure the efficacy of new clinical treatments while ensuring patient safety. Since 2014, more than half of all FDA drug approvals came from ERT-supported studies. Pharma companies, biotechs and CROs have relied on ERT solutions in 10,000+ studies spanning more than three million patients to date. By identifying trial risks before they become problems, ERT enables customers to bring clinical treatments to patients quickly — and with confidence.

    Responsibilities

    In this role you will focus primarily on the effective and efficient delivery of all client deliverables and obligations related to contracted services. You will:

    • Manage internal/external negotiations, customer service, study planning, study set-up, monitoring, and closeout procedures.
    • Promote inter-departmental collaboration to foster a positive team environment, effective communications, and efficient use of resources to meet contractual deadlines.
      • Attend client meetings with Business Development or Operational teams to present company services as needed
      • Actively participate in/lead internal Project Assurance meetings to ensure understanding of customer expectations across departments
      • Work closely with Contracts & Proposals regarding study details and ensure that change orders are implemented for change of scope requirements
    • Assist Business Development with client strategies to improve customer service and to help increase business from existing clients by understanding client needs and overall goals.
    • Provide QC/QA of systems & documents generated by ERT as needed to ensure high quality of deliverables.
    • Maintain and monitor study timelines, deliverables, and study budget and communicate to appropriate members of internal and client teams.
    • Assist with training of new team members, and conduct training sessions/serve as a mentor for existing staff, which includes taking a lead role in the development of training programs for on-going instruction regarding systems, processes, and services.
    • Manage all vendor/partnership relationships on both contractual and scientific level as well as development of new services
    • Communicate financial, operational and resourcing status evaluations to management on a monthly basis
    • Assist with departmental and company goals and objectives and perform other duties, assignments, or special projects as assigned.

    The duties and responsibilities listed in this job description represent the major responsibilities of the position. Other duties and responsibilities may be assigned, as required.  This job description and any attachments do not constitute or represent a contract.

    Qualifications

    Qualified candidates will have:

    • Bachelor Degree and/or proven demonstrated Project Management skills or experience within the pharma-related industry
    • Minimum of two years experience in pharmaceutical field (or related industry experience) required, with an emphasis on project management
    • Knowledge of the pharmaceutical drug development process required
    • Knowledge of cardiology and regulatory/FDA cardiac safety guidance preferred
    • Experience assisting with FDA/regulatory submissions preferred
    • Excellent communication, organizational, interpersonal, multi-tasking, and prioritization skills
    • Ability to work quickly and effectively in high-pressure situations; ability to work with SMEs (cardiologists, biostatisticians, medical writers, etc…)
    • Working knowledge of Microsoft Office products
    • Willingness to travel according to business needs (est. 25%)

    ERT is a growing and rewarding place to advance your career, especially for those who are passionate about finding solutions that improve lives – or save lives – for millions of people around the world.  Our success starts with caring and collaborative people, from the recent college grad who’s just getting started to the seasoned professional with a wealth of knowledge, skills and experience.  Together, we’re making a difference.

     
    ERT is an equal opportunity employer and all qualified applicants receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.



    Options

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

    Connect With Us!

    Not ready to apply? Connect with us for general consideration.