Clinical Data Analyst
Clinical Data Analyst
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Salary Not Disclosed
1 Vacancy
Job Description
When our values align theres no limit to what we can achieve.
At Parexel we all share the same goal - to improve the worlds health. From clinical trials to regulatory consulting and market access every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us no matter what we do at Parexel contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally we do it with empathy and were committed to making a difference.
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:
- Bachelors degree and/or other medical qualifications or relevant industry experience.
Required Experience:
IC
Employment Type
Full Time
