Senior Clinical Data Analyst (South Africa)

Parexel International Corporation

South Africa - Any Region - Home Based

Job Purpose:-

* The Senior Clinical Data Analyst (SCDA) shall independently perform all clinical data cleaning activities on assigned projects, commensurate with experience and/or project role.

* Further responsibilities shall include acting as Study Team Lead, support on data processing activities and study level documents e.g. Protocol Deviation Specification, Data Validation specification, etc.

* The SCDA may act as a Data Management Lead where required.

Key Accountabilities:-

* Assume the ability to meet the requirements of a CDA III roIe with a high degree of proficiency and autonomy

* Lead/Responsible for data cleaning and data review activities e.g. query management.

* Management of project timelines (including creation, review and tracking of plans)

* 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 CRF's. 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 neededQualificationsKnowledge and Experience:

* Experience in clinical research

* Good 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 SOP's 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


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


* Personal skills that include:

o Good interpersonal, oral and written communication skills

o Excellent learning ability

o Work with integrity

* Business / Operational skills that include:

o Commitment to quality

o Understanding of Global Data Operations tasks, specifically within Data Management and Database Programming and relevant data standards

o Sound awareness of relevant regulations, including ICH-GCP, 21CRF11

2021-09-12 00:05:37

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