Clinical Data Analyst II
Clinical Data Analyst II
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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.
Clinical Data Analyst II
This is the early phase team working predominantly on end to end data management activities. Candidate are preferred to have good knowledge on Start up activities.
Data Validation (cleaning):
Responsible for/start to lead data cleaning and data review activities (CoPrimary 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 StartUp 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 OntheJob training.
Address training needs as per Development Goal/s identified.
Skills:
Evidence of strong problemsolving 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 ICHGCP 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 startup conduct and closeout
Basic knowledge of Database setup activities including but not limited to Database Configuration Specifications and setup of Data Validation
Location: Hybrid Bengaluru/Hyderabad
Education:
Bachelors degree and/or other medical qualifications or relevant industry experience.
Required Experience:
IC
Employment Type
Full-Time
