The Clinical Data Analyst I (CDA I) works under guidance and supervision of their Line Manager and/or Subject Matter Experts to perform some of the clinical data cleaning activities on assigned projects, commensurate with experience and/or project role. Further responsibilities shall include support on data processing activities, Data Management documents and data cleaning matrices e.g. Data Validation specification, CRF Completion Guidelines, Protocol Deviation Specification, Mock Shell for Off-line listing, etc.
All tasks should be performed in accordance to corporate quality standards, SOPs/Work Instructions/Guidelines, ICH-GCP and/or other international regulatory requirements.
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.
- 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
- Bachelor’s degree and/or other medical qualifications or relevant industry experience.
