Clinical Data Analyst I

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

At Parexel, we all share the same goal - to improve the world's health. Our endeavors, ranging from clinical trials to regulatory, consulting, and market access, are all driven by a deep conviction in our mission. Regardless of our individual roles, we all contribute in some way to the development of a treatment that will ultimately benefit a patient. We approach our work with empathy and personal commitment, intent on making a difference.

The Clinical Data Analyst I (CDA I) operates under the guidance and supervision of their Line Manager and/or Subject Matter Experts, carrying out clinical data cleaning activities for assigned projects, in accordance with their experience and/or project role. Their responsibilities also include support on data processing activities, Data Management documents, and data cleaning matrices, among things. All tasks are performed in accordance with corporate quality standards, SOPs/Work Instructions/Guidelines, ICH-GCP and/or other international regulatory requirements.

Required Knowledge and Experience for This Role:

• Demonstrable technical ability, potentially with prior experience in Microsoft Office Products (basic computer skills).
• Basic understanding of data management processes and data validation flows (e.g., Data cleaning, DB lock).
• Basic knowledge of applicable ICH-GCP Guidelines, local regulatory requirements, 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.
• Prior experience in the clinical research industry.
• Basic knowledge of medical terminology and coding dictionaries (e.g., MedDRA & WHODRUG).
• Basic understanding 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.

Minimum Education Requirements:

• A Bachelor’s degree, other medical qualifications or relevant industry experience.

Required Skills:

• Strong problem-solving abilities and logical reasoning.
• Commitment to quality, demonstrating a methodical, analytical and accurate approach to work activities (attention to detail).
• Time management and prioritization skills for meeting objectives and timelines.
• A demonstrable ability to work collaboratively within a team environment.
• Good interpersonal, oral and written communication skills.
• Aptitude for learning and knowledge sharing; swift understanding of technologies and new processes.
• Flexibility with respect to work assignments and new learning opportunities; ability to quickly adapt to changing technical environments.
• Accountability in relation to key accountabilities outlined in the job description.
• Fluency in English, both written and spoken.

Key Responsibilities of this Role:

Data Validation (Cleaning):

• Responsible for leading data cleaning and data review activities where applicable (Co-Primary CDA/Primary CDA), such as query management and manual/SAS listing reviews.
• Supporting or leading data processing activities from database setup to database lock, e.g., external vendor data reconciliation.

Data Management Documents/Plans (Trial Master File):

• Performing and/or supporting the setup of DM documents and ensuring proper documentation in line with Standard Operating Procedures and ICH/GCP Guidelines.

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

• Leading or performing user acceptance testing on clinical database setups.
• Reviewing protocols and EDC Entry Screens if necessary.

Data Tracking and Entry:

• Tracking and reviewing CRFs, and supporting data entry when required.

Project Quality Management & Compliance:

• Ensuring compliance with Standard Operating Procedures and ICH/GCP Guidelines.
• Supporting or leading functional QC activities on databases and/or patient data, as per business requirements.

Training:

• Maintaining training compliance according to assigned job roles, including on-the-job training.
• Addressing training needs according to identified development goals.