Clinical Data Analyst I

**++Key Accountabilities++** ++:++

**Data Validation (cleaning)**

* Responsible for/start to lead data cleaning and data review activities (Co-Primary CDA/Primary CDA), e.g. query management and manual/SAS listing reviews.
* Support/start to lead data processing activities from database setup to database lock, e.g. external vendor data reconciliation.

**Data Management Documents/Plans (Trial Master File)**

* Perform and/or support the setup of DM documents and ensure proper documentation as per Standard Operating Procedures, ICH/GCP Guidelines.

**Study Start-Up Activities and User Acceptance Testing (UAT)**

* Start to lead/perform user acceptance testing on clinical database setups.
* Start to review protocols and EDC Entry Screens if required.

**Data Tracking and Entry**

* Track and review CRFs. Support data entry where required.

**Project Quality Management \& Compliance Training**

* Ensure compliance to Standard Operating Procedures, ICH/GCP Guidelines.
* Support/start to lead functional QC activities on databases and/or patient data, as per business needs.
* Maintain training compliance as per Job Roles assigned, including On-the-Job training.
* Address training needs, as per Development Goal/s identified.

**++Skills:++**

* Evidence of strong problem-solving skills and logical reasoning
* Commitment to first time quality, including a methodical, analytical and accurate approach to work activities (attention to detail)
* Time management and prioritization skills in order to meet objectives and timelines
* Evidence of ability to work collaboratively within a team environment
* Good interpersonal, oral and written communication skills
* Learning ability and knowledge sharing approach; swift understanding of technologies and new processes
* A flexible attitude with respect to work assignments and new learning; ability to adjust rapidly to changing technical environments
* Evidence of accountability relative to Key Accountabilities in Job Description
* Written and oral fluency in English

**++Knowledge and Experience++**:

* Demonstrates technical aptitude with awareness/potential prior experience in Microsoft Office Products (basic computer skills).
* Basic understanding of data management processes and data validation flow (e.g. Data cleaning, DB lock)
* Basic understanding of relevant ICH-GCP Guidelines, local regulatory requirements and PAREXEL SOPs and study specific procedures
* Basic knowledge of Clinical Data Management Systems (e.g. InForm, Rave, Veeva, Datalabs, ClinBase.)
* Basic understanding of Clinical Study Team roles within Data Management
* Experience in clinical research industry
* Basic knowledge of medical terminology and coding dictionaries (e.g. MedDRA \& WHODRUG)
* Basic knowledge of Data Management Operational processes and tasks during study start-up, conduct and close-out
* Basic knowledge of Database set-up activities, including but not limited to Database Configuration Specifications and setup of Data Validation

**++Education:++**

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