Key Responsibilities:
Data Validation (Cleaning):
- Responsible for or start to lead data cleaning and data review activities, such as query management and manual/SAS listing reviews.
- Support or start to lead data processing activities, including external vendor data reconciliation.
Data Management Documents/Plans (Trial Master File):
- Perform and/or support the setup of data management documents ensuring proper documentation per SOPs and ICH/GCP guidelines.
Study Start-Up Activities and User Acceptance Testing (UAT):
- Lead or perform user acceptance testing on clinical database setups.
- Review protocols and EDC entry screens if required.
Data Tracking and Entry:
- Track and review case report forms (CRFs).
- Support data entry as needed.
Project Quality Management & Compliance:
- Ensure compliance with SOPs, ICH/GCP guidelines.
- Lead functional QC activities on databases and/or patient data as per business needs.
Training:
- Maintain training compliance per job roles assigned, including on-the-job training.
- Address training needs as per development goals identified.
Skills Required:
- Strong problem-solving skills and logical reasoning.
- Commitment to first-time quality with a methodical, analytical, and accurate approach.
- Time management and prioritization skills.
- Ability to work collaboratively within a team environment.
- Good interpersonal, oral, and written communication skills.
- Learning ability and knowledge-sharing approach.
- Flexible attitude towards work assignments and new learning.
- Accountability relative to key accountabilities in the job description.
- Written and oral fluency in English.
Knowledge and Experience:
- Technical aptitude with awareness or prior experience in Microsoft Office Products.
- Basic understanding of data management processes and data validation flow.
- Basic understanding of 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).
- Understanding of Clinical Study Team roles within Data Management.
- Experience in the 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 setup activities, including database configuration specifications and setup of data validation.
