ERT

Site Manager

Job Location US-OH-Cleveland
Shift
40
Type
Regular Full-Time

Overview

Join ERT's Imaging Team in Cleveland as a Site Manager and take responsibility for directing and managing multiple sites and related services in support of a range of projects and serving as a subject matter expert for client projects to assure high quality, on-time, and on-budget services while promoting excellent client service.

 

ERT is a global data and technology company that minimizes uncertainty and risk in clinical trials so that our customers can move ahead with confidence. With more than 45 years of clinical and therapeutic experience, ERT balances knowledge of what works with a vision for what’s next, so it 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. Over the past four years, more than half of all FDA drug approvals came from ERT-supported studies. Pharma companies, Biotechs, and CROs have relied on ERT solutions in 9,500+ studies spanning 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. For more information, go to ert.com or follow us on LinkedInTwitter, and Facebook.

Responsibilities

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  1. Perform and lead startup activities in the support of the imaging sites in areas such as:
    • Entering/ensuring sites were entered into the company’s ERP (Enterprise Resource Planning) System, the imaging platform being used for the clinical trial and/or other internal systems as required for the project success.
    • Contribute to and support the development of the study specific documents such as:
      • the Imaging Qualification & Survey Process and related documents,
      • the Acquisition Monitoring Process, the Imaging Quality Standards, and the Imaging Monitoring Plan.
    • Distribute and/or carry out the study specific work processes related to the site to include the Survey questionnaires, tracking progress, completion and documentation as designated.
    • Contribute to and support the recommendation of equipment related to the site image acquisition and when a contracted service, facilitate and own the distribution of the appropriate equipment to the applicable sites (e.g., Video cameras, EEG equipment, photography supplies, phantoms).
  2. Perform and lead training activities in the support of the imaging sites in areas such as:
    • Scheduling of logistical and technical trainings with site personnel as defined contracting documentation (i.e. via WebEx, Investigator Meeting, or face to face).
    • Track training progress, follow up with sites as needed to ensure compliance and issue site training certifications upon successful completion.
  3. Perform and lead site compliance activities in areas such as:
    • Monitoring site query resolution and follow up in support of the Imaging QC teams
    • Identifying re-education needs, scheduling and/or conducting re-education as required by the study specific documentation.
    • Tracking or supporting the tracking of designated metrics to support the Study and/or project team, creating or distributing reports as needed.
  4. Provide general support imaging sites directly or by working with the project team and/or Customer Care in areas such as:
    • distribution of trial support materials or information (i.e. image acquisition standards, supplies)
    • system support (i.e. password resets, upload assistance)
  5. Collaborate with the project team(s) in the support study timelines and the financial components of each study, which include:
    • Budget reviews
    • Revenue forecasting
    • Scope changes
    • Invoice reconciliation
  6.  Identify potential study risks and mitigations and escalate as appropriate.

 

OTHER DUTIES AND RESPONSIBILITIES:

  1. Read, comprehend and be able to summarize various study documents (i.e. Clinical Protocol, contracting documents, budget, Imaging Charter) to understand and communicate the role of imaging within the assigned studies.
  2. Provide accurate and detailed project time reports, complete assignments within prescribed and committed timelines, seeking assistance and support when necessary.
  3. Ensure compliance with timely training completion/documentation.
  4. When requested, create or contribute content and present at Investigator Meetings, or other meetings as needed.
  5. When requested, 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
  6. Assist with training new members of the Project team.
  7. Other related assignments, projects and tasks 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.  ERT reserves the right to amend or change this job description to meet the needs of ERT.  This job description and any attachments do not constitute or represent a contract.

 

Qualifications

QUALIFICATIONS AND SKILLS NEEDED:

  1. Bachelor Degree and/or proven demonstrated Project Management skills or experience within the industry, including expertise in primary service line and/or support of studies in multiple service lines
  2. Minimum 3-5 years of experience in project management and or project leadership experience with additional experience preferred in the workflows within one or more of: clinical trial management, healthcare management/operations, pre-clinical research, radiologic or a related science.
  3. Excellent organizational, interpersonal, time management, and prioritization skills
  4. Excellent verbal and written communication skills, including the ability to communicate effectively in English
  5. Must be computer literate with application knowledge of Microsoft Word, Excel, PowerPoint, database querying, e-mail and electronic calendar.
  6. Detail oriented and demonstrated responsiveness to inquiries and requests.
  7. Understanding of risk management and the ability to identify potential problems, escalate and assist in resolution as needed.
  8. Understanding of work in a regulated industry, preferably within pharmaceutical, medical device or medical imaging.
  9. Excellent communication and organizational skills with a strong ability to collaborate in English with teams of research scientists, bioinformaticians, software developers, and external collaborators. Will have frequent interaction with clients, sites, management and staff.
  10. Must have a valid passport and the ability to travel approximately 20%

We are an equal opportunity employer and all qualified applicants will 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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