ERT Data Manager in Boston, Massachusetts
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 LinkedIn, Twitter, and Facebook.
ERT's Data Manager is responsible for ensuring high quality data is obtained, processed and reported to Sponsors and defines the methods and tools ERT uses to provide these services. The Data Manager is the primary contact for all data-related issues for both internal and external teams.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Serve as the primary internal and Sponsor contact for Data Management questions, issues, or concerns including, but not limited to:
Data Management activity timelines
Define the Data Management Plan (DMP)
Collaborate with Sponsors to define study requirements
Determine standard edit checks necessary to ensure clean data and define new edit checks when standard checks are insufficient
Develop Query Guidelines and SEC rules to minimize the query burden on sites while ensuring accurate demography and visit information is obtained
Collaborate with internal teams on study setup requirements such as demographic collection and visit schedule requirements
Communicate contents and commitments in the DMP to the internal CDM teams
Complete data management related pages in EXPERT
Lead the development, review, and finalization of data transfer requirements
Provide or customize ERT standard file specifications, review and/or consult with Sponsor on Sponsor-defined specifications, and coordinate finalization and approval of file specifications between Sponsors and SAS Programmers
Maintain approved file specifications
Perform any required validation of file formats or data content
Submit SAS programming requests for data file creation or edit check creation
Generate sample data from live study data
Provide sample data and the Data Transfer Agreement to the Sponsor teams
Maintain the signed Data Transfer Agreement
Manage database lock activities and timelines with the Sponsor to ensure data integrity and deliverable timelines are met
Serve as primary point of contact for query escalation
Routinely review and resolve escalated queries
Provide consolidated escalated query listings to Sponsor teams
Resolve Sponsor or Site issues escalated through Customer Care
Create and review Data Archives for Sponsors and Sites
Ensure high customer satisfaction by delivering on promises, meeting timelines, and providing excellent customer service at all times.
Identify out of scope requests and elevate these requests to the Project Manager so that they can be properly billed through the Change Order process.
Ensure Data Management Files are up-to-date and comprehensive including, but not limited to, Data Management Plans, Files Specifications, Data Transfer Agreements, Data Correction Forms and Requests, client emails, etc.
Conduct routine status meetings with Sponsor/CRO and internal teams. Provide agenda and meeting minutes to all attendees
Process at least one routine data run per assigned study per quarter and perform all sample, complete and final data sends
Assist in the preparation of monthly reporting by providing metrics as required
OTHER DUTIES AND RESPONSIBILITIES:
Communicate project status clearly with Sponsors and Project Management
Contribute to continuous process improvement including workflow efficiencies and associated workflow documentation
Lead in CAPA issues related to study-specific data management activities
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.
BS/BA Degree in Life Sciences or related field preferred
Minimum of 2 years Data Management or related experience preferably in a clinical research position
Proficient in Microsoft Office applications
Strong organizational, interpersonal, time-management, and problem-solving skills
Ability to manage multiple priorities
Strong attention to detail
Previous SAS or SQL exposure or experience a plus
Ability to communicate effectively in English
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.
External Company Name: eResearch Technology