Clinical Data Analyst II

Summary

Parexel is seeking a Clinical Data Analyst II to support clinical data management activities across assigned projects. The role is responsible for data validation, query management, database setup support, user acceptance testing, documentation, and training in compliance with SOPs, ICH-GCP, and other regulatory requirements.

Responsibilities

• Lead/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
• Perform and/or support the setup of DM documents and ensure proper documentation as per Standard Operating Procedures, ICH/GCP Guidelines
• Lead/perform user acceptance testing on clinical database setups
• 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
• Track and review CRFs. Support data entry where required
• Ensure compliance to Standard Operating Procedures, ICH/GCP Guidelines
• Perform/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
• Provide relevant on-the-job training to staff and project teams as appropriate
• Act as Mentor for other clinical data analysts

Skills

• **Knowledge and Experience**: * Experience in clinical research industry with sound Data Management / Lab experience (minimum 2 years) * 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 * 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 SOP's 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 * Basic knowledge of SAS (programmed listings) * Basic knowledge of Data standards (CDISC) * Strong technical aptitude with awareness/potential prior experience in Microsoft Office Products (basic computer skills)
• **Skills:** * 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 * Written and oral fluency in English
• **Education:** * Bachelor's degree and / or other related medical qualification

Qualifications

Must Haves

• **Knowledge and Experience**: * Experience in clinical research industry with sound Data Management / Lab experience (minimum 2 years) * 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 * 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 SOP's 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 * Basic knowledge of SAS (programmed listings) * Basic knowledge of Data standards (CDISC) * Strong technical aptitude with awareness/potential prior experience in Microsoft Office Products (basic computer skills)
• **Skills:** * 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 * Written and oral fluency in English
• **Education:** * Bachelor's degree and / or other related medical qualification

Benefits

• Remote