Fortrea is a leading global contract research organization (CRO) dedicated to scientific rigor and clinical development excellence. With operations in over 90 countries, we provide a comprehensive range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Our mission is to transform drug and device development for our partners and patients worldwide.
Job Summary
As a Clinical Data Specialist, you will play a vital role on the project team, primarily responsible for conducting clinical data reviews, generating and resolving queries, and managing reconciliation activities. Your efforts will support the Data Management lead in delivering high-quality clinical data that meets client specifications and project timelines.
Key Responsibilities
- Data Review: Conduct clinical trial data reviews according to the Data Management Plan and Data Review Guidelines, raising queries for erroneous or incomplete data.
- Query Management: Generate, resolve, and track queries to address problematic data identified during aggregate data review.
- Project Compliance: Ensure all projects comply with relevant protocols, global SOPs, and GCP standards.
- Data Management Plans: Assist in developing the project Data Management Plan, including data review guidelines and eCRF specifications.
- Systems Setup: Contribute to the setup of data management systems per project requirements.
- Report Generation: Run additional programs and generate QC data listings for internal reviews and Sponsor meetings.
- Training Support: Support the training of new staff on project-specific Data Management processes.
- Documentation: Maintain post Data Management documentation and assist with eTMF maintenance as required.
- Collaboration: Interact with project team members to support data management aspects and participate in relevant meetings.
Who You Are
- Education: Bachelor’s degree in a related field or equivalent experience.
- Experience: Prior experience in clinical data management or a related area is preferred.
- Skills:
- Strong analytical and problem-solving abilities.
- Proficient in data management systems and tools.
- Excellent organizational skills with a focus on detail and quality.
- Strong communication skills and the ability to work collaboratively in a team environment.
- Proficient in Microsoft Excel and other data management software.
