Job Description

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:

• 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:

• 1-2+ years of experience in Clinical Data Management, Clinical Research, Study Start-up, Clinical Operations, Pharmacovigilance, Medical Coding, CRC, CTA, CRA support, or related clinical research functions
• 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.