Clinical Data Analyst I and II - FSP (Remote)

Clinical Data Analyst I (CDA I) works under guidance and supervision of their Line Manager and/or Subject Matter Experts to perform some of the clinical data cleaning activities on assigned projects, commensurate with experience and/or project role. Further responsibilities shall include support on data processing activities, Data Management documents and data cleaning matrices e.g. Data Validation specification, CRF Completion Guidelines, Protocol Deviation Specification, Mock Shell 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.

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.

Key Accountabilities:

Data Validation (cleaning)
Data Management Documents/Plans (Trial Master File)

Study Start-Up Activities and User Acceptance Testing (UAT)

Data Tracking and Entry

Project Quality Management & Compliance

Training

Skills:
•Technical aptitude with awareness/potential prior experience in Microsoft Office Products (strong computer skills).
•Understanding of data management processes and data validation flow (e.g. Data cleaning, DB lock)
•Understanding of relevant ICH-GCP Guidelines, local regulatory requirements
SOPs and study specific procedures
• Knowledge of Clinical Data Management Systems and proficiency in at least one system (e.g. InForm, Rave, Veeva, DataLabs, ClinBase.) 
•Understanding of Clinical Study Team roles within Data Management - awareness of DML activities e.g.: budget reviews, resource forecast, etc.
• Experience in clinical research industry
• Basic knowledge of SAS (programmed listings)
• Basic knowledge of Data standards (CDISC)

• Advanced English level.

Education:

• Bachelor’s degree and/or other medical qualifications or relevant industry experience.