Clinical Data Analyst II
Paglalarawan ng trabaho
Job Summary
We are seeking a Clinical Data Management Associate with 4+ years of experience to support clinical trial data review, data cleaning, query management, and vendor data reconciliation activities. The role involves reviewing clinical data listings, resolving data discrepancies, performing CRF freeze and lock activities, coordinating with internal and external stakeholders, conducting User Acceptance Testing (UAT), and maintaining study documentation within Veeva Vault/eTMF. The ideal candidate will have hands-on experience with EDC systems, clinical data review tools, and a strong understanding of clinical research data management processes.
Skillsets
- Clinical Data Review and Data Cleaning
- Clinical Data Listings Review
- Query Management and Discrepancy Resolution
- Vendor Data Reconciliation, including Local Lab Review
- External Data Review and Reconciliation
- CRF Freeze and Lock Activities
- User Acceptance Testing (UAT) for Listings, Screens, and Edit Checks
- eTMF Documentation and Veeva Vault Management
- Clinical Data Workbench Experience
- Knowledge of Clinical Trial Data Management Processes
- Understanding of ICH-GCP, Regulatory Guidelines, and 21 CFR Part 11
- Cross-functional Collaboration and Stakeholder Management
- Strong Written and Verbal Communication Skills
Tools & Systems:
- EDC: Medidata RAVE (Preferred), Oracle Clinical
- Data Review: J-Review, Spotfire
- Documentation: Veeva Vault, eTMF
- Microsoft Office Suite, Microsoft Project, PowerPoint
Qualification
- Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Clinical Research, or a related scientific discipline.
- Minimum 4+ years of experience in Clinical Data Management within a CRO, pharmaceutical, or biotechnology environment.
- Hands-on experience with EDC systems, preferably Medidata RAVE and Oracle Clinical.
- Experience in data review, query management, vendor reconciliation, and database lock activities.
- Working knowledge of clinical research regulations, GCP guidelines, and clinical trial processes.
- Experience with Veeva Vault and eTMF documentation is preferred.
Location- Hybrid
Mga kasanayang nabanggit
At Parexel, we speed your life-changing medicines to patients through innovative and efficient clinical research. We are proudly among the world's largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help lifesaving treatments reach patients faster. With a dedicated team of over 21,000 global professionals, we partner with biopharmaceutical leaders to design and deliver clinical trials that prioritize patient needs and experiences. In a fast-evolving healthcare landscape, our commitment to inclusivity and diversity in clinical trial participation sets us apart. We focus on ensuring that clinical research is accessible and representative, fostering stronger relationships with communities to enhance healthcare equity. Our approach brings an empathetic focus to clinical trials, ensuring every patient’s voice is heard and valued. By adhering to our core values—Patients First, Quality, Respect, Empowerment, and Accountability—we strive for excellence in every aspect of our work, making a difference in patients' lives globally.
Mag-apply para sa trabahong ito
Use the application link supplied with this listing to apply to Parexel. Check the destination before entering personal information.