Data Management Specialist ensures quality based outcomes through collaboration with clinical staff on study specific issues that impact data collection. Specialists will input all data from source documents into CRFs and perform quality control functions. Specialists will complete data clarification forms and queries in the specified timelines.
To consistently embody AMR’s Core Values:
-
Excellence and Consistency
-
Collaborative Innovation
-
Respect for our Subjects, Sponsors and Team Members
-
Community
-
Unimpeachable Ethics
The Data Management Specialist will report to the Data Management/QC Team Lead.
Classification: Non-Exempt
Primary Responsibilities:
-
Ensure timely and accurate CRF completion for each study subject.
-
Key data for electronic data capture or provide completed CRFs on a timely basis, adhering to the protocol specific data entry timelines.
-
Review entered data for accuracy, completeness, and protocol compliance.
-
Review source documentation for accuracy and work with clinical staff to correct or clarify data as needed.
-
Perform source data verification to crosscheck data in CRF with source documents.
-
Assess the completeness and correctness of adverse events, medical history, and concomitant medication documentation.
-
Upload scanned documents from sites into eSource.
-
Ensure filed documents do not break blind, if applicable.
-
Confirm proper randomization procedures are followed.
-
Submit internal queries to clinical staff as needed.
-
Complete queries and data clarification forms in a timely manner.
-
Work with coordinator to complete SAE information if CRF is used in reporting.
-
At study closure, ensure that all CRFs are complete and that all forms have been entered into the computer as appropriate.
-
Identify trends and systemic training issues and escalate issues to CRC and QA. Copy Site Manager and Clinical Data Manager on escalation notifications.
-
Attend Site Initiation Visits for current assigned protocols.
-
Complete protocol specific, eSource and EDC training, as applicable.
-
Exhibit organization and accuracy in performing assigned work, including but not limited to timeliness in completing projects, neatness of work performed and success in managing multiple tasks.
-
Always maintain professional conduct with colleagues, subjects, research staff, sponsors, and monitors, etc.
-
Maintain communication with sponsors and CROs, if applicable.
-
Communicate issues to your supervisor in a timely manner.
-
Fax, copy, and distribute documents as directed.
-
Other duties or tasks as assigned.
Desired Skills and Qualifications:
-
Ability to learn and become proficient in various Web Based data entry programs.
-
Proven experience demonstrating excellent communication skills and effective organizational skills.
-
Knowledge of clinical research requirements or ability to learn.
-
Strong verbal and interpersonal skills.
-
Highly motivated “self-starter” with the ability to exercise initiative, together with ability to work as a team player as well as independently while managing a variety of projects simultaneously.
-
Advanced knowledge of computer operations and demonstrated computer skills in a variety of software environments, i.e., Word, Excel, and Internet.
-
Regular and predictable attendance is an essential function.
Alliance of Multispecialty Research does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, retaliation, parental status, military service, or other non-merit factor.
** This job description is intended to be a representative summary of the major responsibilities and accountabilities of the staff holding this position. The staff may be requested to perform job-related tasks other than those stated in this description.
