nThe Clinical Data Analyst II (CDA II) performs all clinical data validation activities on assigned projects, commensurate with experience and/or project role with minimal guidance and supervision from Line Manager and/or Subject Matter Expert. Further responsibilities shall include support on data validation activities, Data Management documents and data cleaning matrices e.g. Data Validation Specification, CRF Completion Guidelines, Protocol Deviation Specification, Mock Shells for Off-line listing etc.
nAll tasks should be performed in accordance to corporate quality standards, SOPs/Work Instructions/Guidelines, ICH-GCP and/or other international regulatory requirements.
nData Validation (cleaning)
nLead/Responsible for data validation (cleaning/review/reconciliation) activities during conduct and database lock (Primary CDA), e.g. query management, manual/SAS listing reviews and external vendor data reconciliation.
nData Management Documents/Plans (Trial Master File)
nPerform and/or support the setup of DM documents and ensure proper documentation as per Standard Operating Procedures, ICH/GCP Guidelines.
nStudy Start-Up Activities and User Acceptance Testing (UAT)
nLead/perform user acceptance testing on clinical database setups.
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- Review protocols and EDC Entry Screens if required.
- Provide input on the data management timelines and coordinate the DM operational activities during database set up.
nTrack and review CRFs. Support data entry where required.
nProject Quality Management & Compliance
- Ensure compliance to Standard Operating Procedures, ICH/GCP Guidelines.
- Perform/Lead functional QC activities on databases and/or patient data, as per business needs.
nTraining
- Maintain training compliance as per Job Roles assigned, including On-the-Job training.
- Address training needs, as per Development Goal/s identified.
- Provide relevant on-the-job training to staff and project teams as appropriate
- Act as Mentor for other clinical data analysts.
nSkills:n
- 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
- Ability to coordinate & prioritize tasks for the team when in the Primary CDA role.
- 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
nKnowledge and Experience:n
- Strong technical aptitude with awareness/potential prior experience in Microsoft Office Products (basic computer skills).
- Good understanding of data management processes and data validation flow (e.g. Data cleaning, DB lock)
- Good understanding of relevant ICH-GCP Guidelines, local regulatory requirements and PAREXEL SOPs and study specific procedures
- Good knowledge of Clinical Data Management Systems (e.g. InForm, Rave, Veeva, DataLabs, ClinBase.)
- Good understanding of Clinical Study Team roles within Data Management
- Experience in clinical research industry.
- Good knowledge of medical terminology and coding dictionaries (e.g. MedDRA & WHODRUG)
- Good knowledge of Data Management Operational processes and tasks during study start-up, conduct and close-out
- Good knowledge of Database set-up activities, including but not limited to Database Configuration Specifications and setup of Data Validation
- Basic knowledge of SAS (programmed listings)
- Basic knowledge of Data standards (CDISC)
nEducation:n
- Bachelor's degree and / or other medical qualifications or relevant industry experience.
nLocation: Only office Based- Bengaluru/Hyderabad
