Clinical Data Analyst I

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Key Accountabilities :

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 Training

• •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.
• •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

Education:

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