Does Data speak to you? Are you captivated with the many insights thatData can bring to business decisions and take pride in the knowledge that your work can make such a difference in patients' lives?
Join usat ERTas Data Manager in our growing Data Management team. You will be responsible for ensuring the highest quality data is obtained, processed and reported toour Study Sponsors! In the DM role, you will also help define the methods and tools ERT uses to provide these services.
OurData Manager is the primary contact for all data-related study issues for both internal and external teams, sostrong client-facingskills will be important to your success.
ERT is a global data and technology company that minimizes uncertainty and risk in clinical trials so thatcustomers 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 compromisingstandards.
Powered by the company's EXPERT technology platform, ERT's solutions enhance trial oversight, enable siteoptimization, increase patient engagement and measure the efficacy of new clinical treatments while ensuringpatient 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 thanthree million patients to date. By identifying trial risks before they become problems, ERT enables customersto bring clinical treatments to patients quickly - and with confidence.
In this role, your key responsibilities will include:
Serve as the primary internal and Sponsor contact for Data Management questions, issues, or concerns including, but not limited toData collection, Data cleaning, Data delivery, Data reconciliation, Database lock and Data Management activity timelines
Define the Data Management Plan (DMP), in collaboration with studySponsors to define study requirements and Queryguidelines
Work with internal teams on study setup requirements such as demographic collection and visit schedule requirements. Maintain good communications with relatedteams
Lead the development, review, and finalization of data transfer requirements
Serve as primary point of contact for query escalation
Routinely review and resolve escalated queries
Provide consolidated escalated query listings to Sponsor teams
Prepare study database for archiving 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.
MaintainData Management Files
Conduct routine status meetings with Sponsor/CRO and internal teams
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.
Our ideal candidate will offer:
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. Strong client-facing skills/experience critical to this role. Formal project management experience strongly preferred.
Strong knowledge of CDISC standards. Previous SAS or SQL exposure or experience strongly preferred
CCDM certification very helpful/preferred
Strong organizational, interpersonal, time-management, and problem-solving skills
Ability to manage multiple priorities
Strong attention to detail
Proficient in Microsoft Office applications
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.
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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.