Clinical Data Analyst I

ABOUT THIS ROLE

Clinical Data Analyst I

This is the early phase team working predominantly on end to end data management activities. Candidate are preferred to have good knowledge on Start up activities.

Data Validation (cleaning):

• Responsible for/start to lead data cleaning and data review activities (Co-Primary CDA/Primary CDA), e.g. query management and manual/SAS listing reviews.

• Support/start to lead data processing activities from database setup to database lock, e.g. 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):

• Start to lead/perform user acceptance testing on clinical database setups.

• Start to review protocols and EDC Entry Screens if required.

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.

• Support/start to 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.

Skills:

• Evidence of 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

• 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

Knowledge and Experience:

• Demonstrates technical aptitude with awareness/potential prior experience in Microsoft Office Products (basic computer skills).

• Basic understanding of data management processes and data validation flow (e.g. Data cleaning, DB lock)

• Basic understanding of relevant ICH-GCP Guidelines, local regulatory requirements and Parexel SOPs and study specific procedures

• Basic knowledge of Clinical Data Management Systems (e.g. InForm, Rave, Veeva, Datalabs, ClinBase.)

• Basic understanding of Clinical Study Team roles within Data Management

• Experience in clinical research industry

• Basic knowledge of medical terminology and coding dictionaries (e.g. MedDRA & WHODRUG)

• Basic knowledge of Data Management Operational processes and tasks during study start-up, conduct and close-out

• Basic knowledge of Database set-up activities, including but not limited to Database Configuration Specifications and setup of Data Validation

Location: Hybrid

Education:

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