Clinical Data Associate

Job Description of Clinical Data Associate.

To co-ordinate with the respective Study Lead of the CDM department to ensure effective study progress and support the Study Lead in departmental functions and activities at Cliantha Research.

A. Create, maintain and update study specific documents like Data Management Plan, Creation of Data Validation Plan, database design specifications, external data handling plan and other study specific documents.

B. Designing Case Report Forms for paper and EDC studies and reviewing CRFs design.

C. Receipt and tracking of subject CRFs (for paper based CRF studies).

D. Co-ordinate with other study team members for data management related tasks on study activity.

E. Perform UAT in study database based on the edit checks created.

F. Check consistency of Data Entry screens with case report form.

G. Train the clinical sites on using the study specific database for Electronic Data Capture (EDC) studies and process role-specific database access as per request received.

H. Identify and resolve data discrepancies in clinical data via computerized and manual data checks.

I. Perform data management QC for assigned study.

J. Generate queries, Update and Verify the received DCFs and Ex-DCFs (for paper based CRF studies).

K. Handle the external data and perform the applicable external data reconciliation process and resolve queries pertaining to the external data.

L. Perform Serious Adverse Event (SAE) Reconciliation and resolve queries pertaining to the SAEs.

M. Perform Medical Coding of terms reported on Case Report Form.

N. Be compliant with Standard Operating Procedure, work procedures and project scope of the work and ensure quality.

O. Maintain documentation of training as appropriate.

P. Work with other members of the project team. This includes but is not limited to External team, Programmer, Statistician, Monitor and CRA.

Q. Conforms to training schedule for self, maintains awareness of SOP content in the Data Management team, according to company requirements.

R. Ensure appropriate archival of project data and documents is carried out as per the applicable Archival SOP.