Clinical Data Manager I

Post #
7340
Company
Health Research Inc. (HRI) Roswell Park Division
Department
Biostatistics & Bioinformatics
Hours/Shift
Full-time; Days
Salary
HRI offers a competitive salary and comprehensive benefits package.
Description of Duties

Health Research, Inc. (HRI) Roswell Park Division is seeking a full-time Clinical Data Manager I. The Clinical Data Manager I will be responsible for the collection and quality control of data collected by the Clinical Trial Development Division of the Biostatistics and Bioinformatics Department. Responsibilities include, but are not limited to the following: protocol and study plan development; development of clinical trial database specifications, including electronic Case Report Form (eCRF) design, user requirements, edit checks, query logic and data validations; coordination of User Acceptance Testing (UAT) of eCRF build and validation documents; reconciliation of datasets from the vendor or sponsor with the primary clinical database; The Clinical Data Manager I will also ensure that the clinical data is of quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock.

Qualifications

The applicant must have a Bachelor’s degree in a science or medical field and the equivalent of one year of full-time clinical data management experience; or an Associate’s degree in a science or medical field and the equivalent of three years of full-time clinical data management experience. The preferred candidate will have at least three years of experience performing clinical data management activities for clinical trials. Additional qualifications include: experience creating CRFs using data standards (e.g. common data elements and/or CDASH); experience with the Medidata Rave EDC system; working knowledge of Good Clinical Practices; familiarity with MedDRA coding; and proficiency in Microsoft Office Software (Outlook, Word, Excel, etc.). Experience organizing and leading virtual meetings is also preferred. Additional key competencies include: critical thinking, problem solving skills, adaptability, ability to function as a member of a team, ability to communicate effectively with co-workers, study teams and supervisor(s).
 
This is a grant-funded position. Compliance with funding requirements such as time and effort reporting, grant deliverables, and contract deliverables is required.
Health Research Incorporated (HRI) Roswell Park Division participates in the E-Verify program.
Affirmative Action/Equal Opportunity Employer/Qualified Individuals with Disabilities/Qualified Protected Veterans