Clinical Data Analyst II - based in Romania, Poland, Hungary

at  Parexel

REQUIRED SKILLS AND EXPERIENCE:

• Proven data management experience in clinical research industry (CRO/Pharma)
• Bachelor’s degree and / or other medical qualifications or relevant industry experience
• 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
• Written and oral fluency in English
• 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)
• Strong technical aptitude with awareness/potential prior experience in Microsoft Office Products (basic computer skills)
• Good interpersonal, oral and written communication skills

WHAT YOU WILL DO AT PAREXEL:

Data Validation (cleaning):

• 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

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):

• 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

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.
• Perform/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
• Provide relevant on-the-job training to staff and project teams as appropriate
• Act as Mentor for other clinical data analysts