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

The role can be flexibly based in Romania, Poland, Hungary.

Picture yourself at Parexel:

The 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.
All tasks should be performed in accordance to corporate quality standards, SOPs/Work Instructions/Guidelines, ICH-GCP and/or other international regulatory requirements.
CDA II may act as a mentor for ACDA or other CDA peers and also as a process lead on a specific data validation activity.

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

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