Associate Clinical Data Analyst

The Clinical Data Analyst II (CDA II) shall perform all clinical data cleaning activities on assigned projects, commensurate with experience and/or project role. Further responsibilities shall include support on data processing activities and study level documents e.g. Protocol Deviation Specification, Data Validation specification, etc.

Lead/Responsible for data cleaning and data review

activities e.g. query management.

Review of protocols and EDC Screens if required.

Support data processing activities from database

setup to database lock, e.g. SAE reconciliation.

Perform user acceptance testing on study database

setups.

Perform medical coding on small studies

Track and review CRFs. Support data entry where

required.

Perform and or support the setup of DM documents

and ensure proper documentation e.g. CRF

Completion Guidelines (CCG)

Perform/lead functional QC activities and testing

Mentor project team members

Be a subject matter expert when neededQualificationsGood interpersonal, verbal and written communication skills

 Knowledge of medical terminology and awareness of coding dictionaries (e.g.MedDRA &

WHODRUG)

 Ability to work in team environment

 Good analytical skills and attention to detail

 Effective time management to meet daily metrics or team objectives, completion of assigned

tasks in a timely manner

 Robust knowledge of ICH-GCP Guidelines, local regulatory requirements and PAREXEL SOPs

and study specific procedures

 Good knowledge of EDC systems (e.g. DataLabs, Rave.)

 Good knowledge of electronic source data capture systems (e.g. ClinBase)

 Good knowledge of all DB set- up activities including but not limited to Database Configuration

Specifications, Data Validation

 Basic knowledge of SAS

Education:

 Bachelor’s degree and / or other medical qualifications or relevant industry experience