Clinical Data Manager

Tasks

AIXIAL is an International Contract Research Organization (CRO), a member of the ALTEN Group, providing complex services in clinical trials (phase I-IV) and non-interventional studies. Our offices are located in France, Belgium, Germany, Czech Republic and India.

Due to fast growth of our company we are currently recruiting a colleague for the position of an Clinical Data Manager, the position would be based in Pune.

Tasks:

-Learning all workflows type and their specificities

-FTS (File Transfer Specification) writing in accordance with study start-up documentation, Standard, vendor specificities and study team constraint (timelines)

-Perform UAT in EDL Tool and check if data are well loaded in Clinical Database

-Check the data conformance and make FTS/EDL update if needed

-Check reconciliation report generated by EDL tool and provide advice to Data Manager regarding the way to clean data (CAPA)

-Attend all team meeting

-Provide support to study team/external vendor regarding EDL and FTS aspect

Requirements

Mandatory to have:

-Data management skills

-English written and spoken

-Rigorous/Motivated

-Team spirit

-Critical spirit

-Good communication mandatory due to much interaction with study teams, vendors, EDL Team

-Office Pack (Work, excel, Power point) proficiency

-Adaptability and capacity to switch process quickly according to constraints

Nice to have:

-Rave knowledge

-Sharepoint knowledge