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
- 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.
Training
- 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
Location: Hybrid
Education
- Bachelor’s degree and/or other medical qualifications or relevant industry experience.