ERT

  • Lead Project Manager - eCOA Clinical Studies

    Job Location US-MA-Boston | US-PA-Pittsburgh
    Shift
    Full-time
    Type
    Regular Full-Time
  • Overview

    Are you passionate about the clinical trial industry and believe technology is the way to innovate better health? Do people come to you naturally for guidance and your insights? Then consider joining us as a Lead Project Manager with our eCOA service line, where you will be responsible for staff management, and directing and managing services for high-visibility client projects to assure high quality, on-time, and on-budget services while promoting excellent customer service.

     

     

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    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: 

    1. Management of assigned eCOA Project Management team members, including:
        • Mentoring and defining career paths by developing core competencies
        • Ensuring proper training is executed and documented
        • Conducting reviews of system set-ups and documents to ensure high quality of deliverables in accordance with quality standards and SOPs
        • Coordinating routine status meetings to facilitate communications, monitor workload, and provide forecasting guidance
        • Collecting and monitoring defined staff metrics 
    1. Independently lead the Planning and Setup, Monitoring, and Closeout phases of your own (high visibility) eCOA program/study management projects, including:
        • Gathering customer requirements and relaying to internal teams
        • Developing study documentation
        • Distributing/tracking equipment
        • Creating/distributing reports
        • Archiving study data and documentation
        • Appropriate setting and fulfilling of customer expectations 
    1. Monitor study timelines and manage the financial components of each program/study.
    1. Identify potential study risks and mitigations, and escalate as appropriate. 
    1. Manage internal/external negotiations and promote collaboration to foster a positive team environment, effective communications, and efficient use of resources to meet study timelines and contractual obligations. 
    1. Develop and apply problem solving strategies to address customer issues and maintain issue tracking documentation to monitor progress and ensure timely resolution to customer escalations. 
    1. Provide primary service line support to cross-trained team members from other service lines. 
    1. Influence strategic decision making and implement departmental objectives according to schedule. 
    1. Ensure compliance with timely training completion/documentation. 
    1. Present study services at Investigator Meetings or site initiation meetings as needed. 
    1. Attend client meetings with Business Development and/or Operational teams to present Company services and Operational Data flow, as needed and participate in sales initiatives to generate incremental revenue. 
    1. Assist with developing training plans and training new members of the Project Management team.

     

    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.  ERT reserves the right to change or amend these job duties to meet business needs. This job description and any attachments do not constitute or represent a contract.

    Qualifications

    Qualified candidates will have:

    1. Bachelor Degree and proven Project Management skills or experience within the Clinical Trials/Clinical Studies industry, including expertise in primary service line and/or support of studies in multiple service lines
    2. Demonstrated success in mentoring staff
    3. 4-8 years of experience in pharmaceutical, clinical trials or related industry experience, with an emphasis on data-based project management
    4. Knowledge of the drug development process
    5. Excellent organizational, interpersonal, time management, and prioritization skills
    6. Excellent verbal and written communication skills, including ability to communicate effectively in English
    7. Working knowledge of Microsoft Office products
    8. Detail oriented and demonstrated responsiveness to inquiries and requests
    9. Valid passport and ability to travel approximately 20%

     

    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.

     

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