Seeking a job where you can make a difference every day?
Join ERT as a Reader Manager and take responsibility for directing and managing multiple readers 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.
ERTis 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 EXPERTtechnology 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 toert.comor follow us onLinkedIn,Twitter,andFacebook.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Perform and lead startup activities in the support of the reader selection process by tasks such as:Contribute to, support the development of and/or understand and adhere to the study specific documents such as:the Imaging Quality Standards,
the Image Interpretation Standards
the Image Interpretation eCRF
Reader Selection Standards and related processes
Reader Training Process and related materials
and the Image Monitoring Plan
Understanding of the specific reader requirements of the study and the presentation of appropriate reader candidates to the sponsor for approval decision.
Facilitate any determined reader contracting needs across multiple areas within ERT.
Collection and maintenance of all reader compliance documentation and training such as, but not limited to, GCP Training, study specific training, and medical licensure.
Collaborate with the cross functional Imaging team members and authorities to ensure the specification and use of the appropriate equipment (i.e. workstations/laptops) in the read environment is defined and then carried out throughout the study.
Facilitate reader equipment use in the execution of the Work Order, ordering equipment and/or traveling for setup if applicable to the Study.
Perform and lead Reader training and support activities in areas such by performing tasks such as:Read, comprehend, and explain various study documents (Clinical Investigation Protocol, client contracts, evaluation criteria, etc.) to understand and communicate the role of the reader within the study and the parameters in which they are permitted
Understand and have necessary proficiency in the software used for the expert review
Facilitate and conduct reader training/retraining and insure compliance of training and related requirements and/or documentation.
Perform and lead reader compliance activities in areas such as:When applicable set up the expert reviews as defined by the protocol design or as directed by the project manager.
Support of the reader during the expert reviews to include managing turnaround time (TAT) windows and adherence to training
Issuing, tracking and working until resolution any reader queries
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.
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 interpretation standards, supplies)
system support (i.e. password resets, read assistance)
Collaborate with the project team(s) in the support study timelines and the financial components of each study, which include:Budget reviews
Identify potential study risks and mitigations and escalate as appropriate.
OTHER DUTIES AND RESPONSIBILITIES:
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.
Provide accurate and detailed project time reports, complete assignments within prescribed and committed timelines, seeking assistance and support when necessary.
Ensure compliance with timely training completion/documentation.
When requested, create or contribute content and present at Investigator Meetings, site initiation or other meetings as needed.
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
Assist with training new members of the Project team.
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 AND SKILLS NEEDED:
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
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.
Excellent organizational, interpersonal, time management, and prioritization skills
Excellent verbal and written communication skills, including the ability to communicate effectively in English
Must be computer literate with application knowledge of Microsoft Word, Excel, PowerPoint, database querying, e-mail and electronic calendar.
Detail oriented and demonstrated responsiveness to inquiries and requests.
Understanding of risk management and the ability to identify potential problems, escalate and assist in resolution as needed.
Understanding of work in a regulated industry, preferably within pharmaceutical, medical device or medical imaging.
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.
Must have a valid passport and the ability to travel approximately 10%.
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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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.