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.
The Clinical Data Analyst 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 with corporate quality standards, SOPs/Work Instructions/Guidelines, ICH-GCP and/or other international regulatory requirements.
The 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.
What you'll bring to the role;
Knowledge and Experience:
- Experience in clinical research industry with sound Data Management / Lab experience (minimum 2 years)
- Good knowledge of medical terminology and coding dictionaries (e.g. MedDRA & WHODRUG)
- Good knowledge of Data Management Operational processes and tasks during study start-up, conduct and close-out
- Good knowledge of Database set-up activities, including but not limited to Database Configuration Specifications and setup of Data Validation
- Good understanding of data management processes and data validation flow (e.g. Data cleaning, DB lock)
- Good understanding of relevant ICH-GCP Guidelines, local regulatory requirements and Parexel SOP's and study specific procedures
- Good knowledge of Clinical Data Management Systems (e.g. InForm, Rave, Veeva, DataLabs, ClinBase.)
- Good understanding of Clinical Study Team roles within Data Management
- Basic knowledge of SAS (programmed listings)
- Basic knowledge of Data standards (CDISC)
- Strong technical aptitude with awareness/potential prior experience in Microsoft Office Products (basic computer skills).
Skills:
- 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
- Ability to coordinate & prioritize tasks for the team when in the Primary CDA role
- 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
- Written and oral fluency in English
Education:
- Bachelor’s degree and / or other related medical qualification
Your Core Responsibilities:
Data Validation (cleaning)
- Lead/Responsible for data validation (cleaning/review/reconciliation) activities during conduct and database lock (Primary CDA), e.g. query management, manual/SAS listing reviews and 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)
- Lead/perform user acceptance testing on clinical database setups.
- Review protocols and EDC Entry Screens if required.
- Provide input on the data management timelines and coordinate the DM operational activities during database set up.
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.
- Perform/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.
- Provide relevant on-the-job training to staff and project teams as appropriate
- Act as Mentor for other clinical data analysts.
